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seleon gmbh
Im Zukunftspark 1,
74076
Heilbronn
Germany
Germany
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Websession Video: Digital Technical Documentation - Concept and Implementation of Knowledge Units
seleon gmbh
Websession Video: Post Market Surveillance and Post Market Clinical Follow-Up in times of the new MDR
seleon gmbh
Websession Video: Secure software and cybersecurity – a new dimension in software development
seleon gmbh
Websession Video: Legal Manufacturer as a Service
seleon gmbh
seleon gmbh
Websession Video: Software – a great unknown in device development
seleon gmbh
Websession Video: Stellt die MDR mein QMS auf den Kopf? - Die (neuen) Anforderungen an das QM-System
Contact
Peter Hartung
Head of Business Unit Consulting
Fabiola Hartung-Linz
Sales Manager Consulting / Marketing Manager
Benjamin Klein
Director Business Development Engineering
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16 Nov 2020
Topic
10:40 - 11:10
Digital Technical Documentation - Concept and Implementation of the "Knowledge Units"
Have you missed our presentation? Do not be sad! Here you can watch it without hectic:
https://vimeo.com/479908832
Welcome to the future of digital technical documentation for medical devices!
Medical Device Knowledge Units represent an innovative, open source data model for the medical device industry, which allows the contents of technical documentation of medical devices to be efficiently represented in digital form.
The core element is the transfer of documents to individual information units (Knowledge Unit, "KU"), which are intelligently managed in a database. With the help of attributes, the individual Knowledge Units can be assigned to both technical topics (e.g. risk management, usability, clinical evaluation, cybersecurity) and products or product groups and reused as required. The creation and maintenance of technical documentation documents is simplified and accelerated by using existing knowledge units. In addition, redundancies and inconsistencies are avoided.
Result: Inefficiencies in the creation, maintenance and modification of technical documentation content can be eliminated and the maintenance effort can be reduced in the long term.
11:20 - 11:50
Post Market Surveillance and Post Market Clinical Follow-Up in times of the new Medical Device Regulation
Have you missed our presentation? Do not be sad! Here you can watch it without hectic:
https://vimeo.com/479909355
The lecture provides a short overview about the most important terms, definitions, and expectations of the new medical device regulation according to the implementation of proper PMS and PMCF systems and processes for medical devices.
17 Nov 2020
Topic
10:40 - 11:10
Secure software and cybersecurity – a new dimension in software development
Have you missed our presentation? Do not be sad! Here you can watch it without hectic:
https://vimeo.com/480347806
In recent years use of software in medical technology has increased significantly. With growing complexity and connectivity, security of software is becoming more important. Following aspects shall be discussed:
- Overview of the regulatory landscape
- Pragmatic approach
- What are typical "mistakes" and examples of best practice
12:00 - 12:30
Legal Manufacturer as a Service
Have you missed our presentation? Do not be sad! Here you can watch it without hectic:
https://vimeo.com/480348802
For decades our clients appreciate seleon as a reliable partner in all aspects of engineering, production and regulatory as well as clinical affairs.
As a logical continuation seleon now extended its services: in addition to our one-stop-shop we can take the role of the Legal Manufacturer. This solution substantially reduces the regulatory overhead burden especially for start-up or cross-entry entities.
Additionally the seamless integration of our network partners make even more services available to our customers just under one roof, like market access strategy and support, KOL generation and clinical networking, and many more.
Our novel, encompassing solution enables entrepreneurs and idea-givers to concentrate on their medtech innovation and its medical and market success. We will significantly shorten time-to-market and lower overall business risk.
In the presentation we will give an overview of this new service and explain its motivations and benefits for our clients.
18 Nov 2020
Topic
10:40 - 11:10
"Stellt die MDR mein QMS auf den Kopf?" - Die (neuen) Anforderungen an das QM-System
Have you missed our presentation? Do not be sad! Here you can watch it without hectic:
https://vimeo.com/480801943
Die MDR ist verschoben, die neu anzuwendenden Anforderungen ans QMS bleiben. Haben Sie schon alle Punkte eingearbeitet? Fühlen Sie sich gut auf Ihr erstes MDR Audit vorbereitet?
12:00 - 12:30
Software – a great unknown in device development
Have you missed our presentation? Do not be sad! Here you can watch it without hectic:
https://vimeo.com/480801403
Software in medical technology is often more difficult to understand as it follows different rules compared to pure hardware development. The potential is great, as software offers more flexibility, while at the same time the overall complexity of the entire system and the documentation efforts increase.
The presentation is intended to provide a basic understanding and a pragmatic approach to the great unknown "software":
- Basic complexity considerations and general logic structure
- Introduction of typical diagram types and their purpose
- Standards landscape and risk management
- Common software development steps and their justification
- Examples of best practice
Our range of products
Product categories
- 01 Manufacturing of components
- 01.01 Electronic manufacturing services (EMS)
- 01.01.02 Electronics development
Electronics development
- 01 Manufacturing of components
- 01.08 Rapid prototyping
Rapid prototyping
- 01 Manufacturing of components
- 01.09 Other component manufacturing
Other component manufacturing
- 02 Manufacturing of finished products
- 02.09 Electromedical devices
Electromedical devices
- 02 Manufacturing of finished products
- 02.10 Endoscopes
Endoscopes
- 02 Manufacturing of finished products
- 02.11 Wearables
Wearables
- 02 Manufacturing of finished products
- 02.12 Dental products
Dental products
- 02 Manufacturing of finished products
- 02.13 OR infrastructure
OR infrastructure
- 03 Services
- 03.02 Consulting (services)
- 03.02.03 Education, training
Education, training
- 03 Services
- 03.02 Consulting (services)
- 03.02.04 Regulatory affairs
Regulatory affairs
- 03 Services
- 03.02 Consulting (services)
- 03.02.05 Documentation
Documentation
- 03 Services
- 03.02 Consulting (services)
- 03.02.06 Clinical trials
Clinical trials
- 03 Services
- 03.02 Consulting (services)
- 03.02.07 Medical device approval
Medical device approval
- 03 Services
- 03.04 Design and development
- 03.04.01 Product design, product development
Product design, product development
- 03 Services
- 03.05 Assembly
- 03 Services
- 03.07 Labeling
Labeling
- 03 Services
- 03.09 Testing services
- 03.09.06 Auditing
- 03 Services
- 03.10 Other services
Other services
- 04 Manufacturing equipment
- 04.07 Assembly systems
Assembly systems
- 04 Manufacturing equipment
- 04.11 Quality assurance
- 04.11.03 Measuring technolgy, testing technology
Measuring technolgy, testing technology
- 06 Electrical components, electronical components
- 06.07 Embedded systems
Embedded systems
- 09 Software, IT
- 09.03 Software development
Software development
- 09 Software, IT
- 09.04 Software as medical product
Software as medical product
- 09 Software, IT
- 09.06 Medical apps
Medical apps
Our products
Product category: Electronics development, Rapid prototyping, Other component manufacturing, Electromedical devices, Endoscopes, Wearables, Dental products, OR infrastructure, Education, training, Documentation, Product design, product development, Labeling, Measuring technolgy, testing technology, Embedded systems, Software development, Software as medical product, Medical apps
Product development
seleon "rock solid medical engineering made in Germany" has a clear objective:
we transform your ideas into products at the pinnacle of medical technology development. Our customers benefit from our many years of industry experience and our comprehensive process and methodology know-how. For housings and carriers, controllers and sensors, valves, mixers, compressors, fans, pumps, software and much more.
You have access to all specialist departments required for the development of complex medical technology systems. The specialised knowledge of our interdisciplinary development team is available to you throughout the entire product development process – from conceptual design to the development of functional models and prototypes to approval and the transfer to series production.
By bundling all process steps for a project, our customers can realise crucial cost advantages while saving time and ultimately obtaining the best possible result for market success.
we transform your ideas into products at the pinnacle of medical technology development. Our customers benefit from our many years of industry experience and our comprehensive process and methodology know-how. For housings and carriers, controllers and sensors, valves, mixers, compressors, fans, pumps, software and much more.
You have access to all specialist departments required for the development of complex medical technology systems. The specialised knowledge of our interdisciplinary development team is available to you throughout the entire product development process – from conceptual design to the development of functional models and prototypes to approval and the transfer to series production.
By bundling all process steps for a project, our customers can realise crucial cost advantages while saving time and ultimately obtaining the best possible result for market success.
- Project management
- System development
- Electronics
- Software / Firmware
- Mechanics / Mechatronics / Design
- Product documentation / Product testing
Product category: Other component manufacturing, Electromedical devices, Endoscopes, Wearables, Dental products, OR infrastructure, Education, training, Regulatory affairs, Documentation, Clinical trials, Medical device approval, Labeling, Auditing, Other services, Embedded systems, Software as medical product, Medical apps
Consulting QM & RA
NAVIGATE THROUGH MEDDEV, MDR & ISO TERRITORY SAFELY with seleon.
To keep your ideas for medical technology innovations from bursting before they reach the market.
We are not "THE CONSULTANTS" but engineers, physicians and QM experts with established technical expertise based on numerous international development, production and approval projects.
Our customers – ranging from small and midsize enterprises to large corporate groups – benefit from this expertise in our consulting projects:
What we have always liked to do:
To keep your ideas for medical technology innovations from bursting before they reach the market.
We are not "THE CONSULTANTS" but engineers, physicians and QM experts with established technical expertise based on numerous international development, production and approval projects.
Our customers – ranging from small and midsize enterprises to large corporate groups – benefit from this expertise in our consulting projects:
- We meet the very highest quality, safety and process standards, for example in the conceptual design, realisation and approval of life-sustaining systems.
- We meet the various requirements of the respective national approval authorities for you.
- Starting from concept and planning towards creation of clinical evaluation reports and conduction of clinical investigations/studies: We establish the clinical evaluation for you.
- From QM light to QM XXL, we offer tailor-made solutions for your enterprise and products.
- We are also happy to support you on site in your company.
What we have always liked to do:
- Regulatory Affairs Consulting
- Quality management consulting
- Clinical Support - Clinical Affairs, Clinical Research Organisation (CRO)
- Product Lifecycle Management Consulting
- Support on approval Medical Apps / Health Software
- Digitisation of Technical Documentation
- Digital Computer System Validation (D-CSV)
- Cyber Security, DiGa, Data Protection
- International registrations (MDSAP countries, PRC, Russia)
- Support over the entire product life cycle
- Taking over the role of the "Legal Manufacturer" / "Legal host"
- Support on approval of borderline products
- Usability Engineering Consulting
- Clinical Strategy Consulting
- Technology Consulting (One Stop Shop Competence)
- Regulatory Due Diligence
Product category: Other component manufacturing, Electromedical devices, Endoscopes, Wearables, Dental products, OR infrastructure, Education, training, Regulatory affairs, Documentation, Clinical trials, Medical device approval, Other services, Software as medical product, Medical apps
Clinical Approval, Clinical Research Organisation (CRO)
Business activities of seleon include:
We ensure that the qualification and competence for performing a clinical evaluation are given:
Our experienced CRO consultants organize for you and support you with:
We document the safety and benefits of your medical device:
- Pre-clinical and clinical evaluations
- Clinical Study/Investigation
- Post Market Surveillance (PMS), Vigilance, Post Market Clinical follow-up (PMCF)
We ensure that the qualification and competence for performing a clinical evaluation are given:
- Analysis of your products degree of innovation and relevant clinical risks
- Feasibility study for product development
- Identification and evaluation of equivalent devices - also for 510(k) applications at the FDA
- Creation of a Clinical Evaluation Plan and a market approval strategy
- Performance of a clinical evaluation in accordance with MEDDEV 2.7/1 Revision 4 including the clinical evaluation report (CER)
- Scientific literature search on the planned application (Indication, prevalence, state of art of therapy and diagnosis)
- Scientific literature search on equivalent devices
- Assessment of the relevance (PICO) and methodological quality of the clinical data gained
- Inclusion and evaluation of Post Market Surveillance Data
- Sound standing consultation for the decision to conduct a clinical investigation/study
- Analysis of the clinical data and evaluation of the conformity with the relevant essential principles (safety, performance, benefit/risk relation, side effects)
Our experienced CRO consultants organize for you and support you with:
- Defining the objectives and hypotheses of a clinical investigation/study according to EN ISO 14155
- Conduction of different study types (PMCF, IIT, Pivotal trials, reimbursementstudies)
- Preparing the necessary (minimum) technical documentation
- Establishing the study site and interfaces
- Drafting contracts and organizing insurance coverage
- Obtaining initial approval for a clinical study
- Project management of the clinical investigation incl. budget management
- Constant monitoring as well as supervision and coordination between the involved parties
- Ensuring test documentation, data management and data safety
- Surveillance of compliance according regulatory requirements
- Evaluation of data resulting from clinical investigations taking statistic, biometric and other aspects into account
- Drafting or reviewing the clinical investigation report
- Medical Writing considering relevant data, regulatory requirements and current formats
We document the safety and benefits of your medical device:
- Conducting the annual market surveillance with monitoring of the schedule
- Analysis of the clinical evaluation, the risk management file and the usability engineering files for their on-going validity
- Collection, assessment and reporting of incidents
- Drafting of “Field Safety Notices (FSN)”, “Field Safety Corrective Action (FSCA)” Plan (Article 89 MDR)
- Post-market surveillance report as per Article 85 MDR
- Drafting and maintaining the periodic safety update report as per Article 86 MDR
- Scientific literature research as a continuation of the clinical evaluation regarding new insights from literature and regarding the safety and benefits of the product being evaluated
- Research of current professional association guidelines and official information
- Analysis of incidents reported to the manufacturer for the product and comparable products according to MEDDEV 2.12-1
- Market observation research through international databases
- Risk assessment regarding reported incidents
- Support in deciding on the need for post-market clinical follow-up studies
Product category: Rapid prototyping, Other component manufacturing, Electromedical devices, Endoscopes, Wearables, Dental products, OR infrastructure, Education, training, Assembly, Labeling, Other services, Assembly systems, Measuring technolgy, testing technology
Production
PRODUCTION
As an assembler, all of seleon’s know-how depends on its employees. All components, test equipment and tools required for assembly are supplied to seleon, where they are assembled into the desired new products.
The synergies of close coordination between development and production are realised in the fabrication of highly specialised devices, produced mainly for the medical technology sector. But since seleon has experience with highly precise technical specifications, we also meet the requirements to serve as a partner in other sectors such as the aerospace industry.
As an assembler, all of seleon’s know-how depends on its employees. All components, test equipment and tools required for assembly are supplied to seleon, where they are assembled into the desired new products.
The synergies of close coordination between development and production are realised in the fabrication of highly specialised devices, produced mainly for the medical technology sector. But since seleon has experience with highly precise technical specifications, we also meet the requirements to serve as a partner in other sectors such as the aerospace industry.
- Prototypes and make-to-order production, zero and initial series as well as small and medium series are produced at the Dessau production site by customer request.
- Supply Chain Management
- Preparation and updating of detailed documentation, describing the development, testing and production processes, required as the foundation of quality management as well as certification measures
- Specialised systems
- Production and test equipment
- Quality management
Product category: Electronics development, Rapid prototyping, Other component manufacturing, Electromedical devices, OR infrastructure, Regulatory affairs, Documentation, Clinical trials, Medical device approval, Product design, product development, Assembly, Labeling, Other services, Assembly systems, Measuring technolgy, testing technology, Embedded systems, Software development, Auditing
Ventilation
Here are a few project examples from seleon in the field of ventilation.
CPAP, AUTOCPAP, BI-LEVEL CPAP – DEVICES FOR THE TREATMENT OF SLEEP APNOEA
CPAP devices are used to prevent apnoea while sleeping. In addition to standard devices (CPAP), therapy devices with automatic pressure adjustment (AutoCPAP) and those with different pressures for inhalation and exhalation (BiLevel) are produced as well.
The Delphinus and Doroado devices developed by seleon set standards in terms of comfort and performance. Highly dynamic pressure control can be realised thanks to the patented algorithm to monitor breathing. This enables an extraordinarily fast reaction at the beginning of the inhalation phase and prevents the feeling of being short of air.
In addition to quiet operation, the CPAP devices can guarantee that the required ventilation system performance is available for the user at all times.
TNI®20 – THERAPIE WITH NASALER INSUFFLATION
The TNI®20 is used for sleep-related breathing disturbances. It was developed as a highly comfortable alternative to breathing therapy devices on the market.
seleon developed and produced the TNI®20, consisting of three components: ventilator, humidifier and applicator. A patented lateral channel blower developed especially for this purpose is used as the air source, setting itself apart with a very high efficiency factor and low noise development. The acoustic containment of the blower requires internal, two-stage air cooling that dissipates the thermal losses at 0.5 K/W. The applicator features heating to just before the user’s nose so that high-humidity warmed air maximises user comfort.
HOME VENTILATION
Strict requirements are imposed on the development of an air humidifier for home ventilation: adequate warming and humidification of the breathing air while simultaneously preventing possible condensation of the humidified air in the ventilation hose. Operation and handling by the patient in the home environment imposes special requirements for the usability and cleaning of the system.
Possible error sources in operation are identified and eliminated in a timely manner with the help of prototype studies on test subjects. Breathing air conditioning (the warming of breathing air to 37 °C with simultaneous humidification to nearly 100%) is among the key issues in patient ventilation.
INTENSIVE VENTILATION WITH HUMIDIFIED AIR
seleon developed two versions for invasive and non-invasive ventilation:
DIGITAL GAS MIXER FOR VENTILATION AND ANAESTHESIA EQUIPMENT
The Digital Gas Mixer is used to produce specified oxygen concentrations (from compressed air and oxygen) or mixtures of no more than four gases. As a modular assembly, it is integrated into various ventilators in paediatrics and into anaesthesia equipment.
The Gas Mixer is suitable for a variety of applications in various ventilators and anaesthesia equipment with different requirements and measuring ranges. The oxygen concentration, pressure and flow rate are adjustable. seleon’s comprehensive expertise and experience in the field of ventilator technology led to an intelligent solution in the course of the development process, resulting in a patent.
The entire development and production process for the device was handled internally by seleon according to the DIN EN ISO 13485 standard. The customer received the product developed according to its ideas and holds the patent. Cost-conscious development and production were realised. Device repairs and service are handled on behalf of the customer.
AIRTRUST® MED – AIR COMPRESSOR
The airtrust® med is a quiet, compact and powerful air compressor intended to supply clinical ventilators with clean, high quality compressed air.
Due to the combination of proven compressor technology, robust controls and minimal maintenance requirements, the airtrust® med is a reliable piece of equipment for everyday clinical use or in areas where the compressed air supply is missing or unreliable.
The airtrust® med starts up automatically if the pressure of the central compressed air supply drops below a specified value or if a medical compressed air supply is generally unavailable.
Two versions of the compressor are available. The airtrust® med dry features an additional membrane dryer, therefore allowing for the use of high humidity ambient air or if the air supply must meet special requirements.
Even for small production runs, the OEM compressor can be modified to meet special customer-specific requirements. Customer requirements can be implemented quickly and easily through elements such as the modular firmware concept, the graphical user interface, and an extendible pressure range. Additional interface languages or a customer-specific design are easy to implement.
CPAP, AUTOCPAP, BI-LEVEL CPAP – DEVICES FOR THE TREATMENT OF SLEEP APNOEA
CPAP devices are used to prevent apnoea while sleeping. In addition to standard devices (CPAP), therapy devices with automatic pressure adjustment (AutoCPAP) and those with different pressures for inhalation and exhalation (BiLevel) are produced as well.
The Delphinus and Doroado devices developed by seleon set standards in terms of comfort and performance. Highly dynamic pressure control can be realised thanks to the patented algorithm to monitor breathing. This enables an extraordinarily fast reaction at the beginning of the inhalation phase and prevents the feeling of being short of air.
In addition to quiet operation, the CPAP devices can guarantee that the required ventilation system performance is available for the user at all times.
TNI®20 – THERAPIE WITH NASALER INSUFFLATION
The TNI®20 is used for sleep-related breathing disturbances. It was developed as a highly comfortable alternative to breathing therapy devices on the market.
seleon developed and produced the TNI®20, consisting of three components: ventilator, humidifier and applicator. A patented lateral channel blower developed especially for this purpose is used as the air source, setting itself apart with a very high efficiency factor and low noise development. The acoustic containment of the blower requires internal, two-stage air cooling that dissipates the thermal losses at 0.5 K/W. The applicator features heating to just before the user’s nose so that high-humidity warmed air maximises user comfort.
HOME VENTILATION
Strict requirements are imposed on the development of an air humidifier for home ventilation: adequate warming and humidification of the breathing air while simultaneously preventing possible condensation of the humidified air in the ventilation hose. Operation and handling by the patient in the home environment imposes special requirements for the usability and cleaning of the system.
Possible error sources in operation are identified and eliminated in a timely manner with the help of prototype studies on test subjects. Breathing air conditioning (the warming of breathing air to 37 °C with simultaneous humidification to nearly 100%) is among the key issues in patient ventilation.
INTENSIVE VENTILATION WITH HUMIDIFIED AIR
seleon developed two versions for invasive and non-invasive ventilation:
- The integrated version is part of a system that also includes the ventilator itself. Operation of the breathing air humidifier is entirely through the ventilator.
- The standalone version is a self-contained unit with its own user interface used to configure all parameters. This version of the breathing air humidifier has a serial interface and can be used with virtually all ventilators on the market.
DIGITAL GAS MIXER FOR VENTILATION AND ANAESTHESIA EQUIPMENT
The Digital Gas Mixer is used to produce specified oxygen concentrations (from compressed air and oxygen) or mixtures of no more than four gases. As a modular assembly, it is integrated into various ventilators in paediatrics and into anaesthesia equipment.
The Gas Mixer is suitable for a variety of applications in various ventilators and anaesthesia equipment with different requirements and measuring ranges. The oxygen concentration, pressure and flow rate are adjustable. seleon’s comprehensive expertise and experience in the field of ventilator technology led to an intelligent solution in the course of the development process, resulting in a patent.
The entire development and production process for the device was handled internally by seleon according to the DIN EN ISO 13485 standard. The customer received the product developed according to its ideas and holds the patent. Cost-conscious development and production were realised. Device repairs and service are handled on behalf of the customer.
AIRTRUST® MED – AIR COMPRESSOR
The airtrust® med is a quiet, compact and powerful air compressor intended to supply clinical ventilators with clean, high quality compressed air.
Due to the combination of proven compressor technology, robust controls and minimal maintenance requirements, the airtrust® med is a reliable piece of equipment for everyday clinical use or in areas where the compressed air supply is missing or unreliable.
The airtrust® med starts up automatically if the pressure of the central compressed air supply drops below a specified value or if a medical compressed air supply is generally unavailable.
Two versions of the compressor are available. The airtrust® med dry features an additional membrane dryer, therefore allowing for the use of high humidity ambient air or if the air supply must meet special requirements.
Even for small production runs, the OEM compressor can be modified to meet special customer-specific requirements. Customer requirements can be implemented quickly and easily through elements such as the modular firmware concept, the graphical user interface, and an extendible pressure range. Additional interface languages or a customer-specific design are easy to implement.
Product category: Electronics development, Rapid prototyping, Other component manufacturing, Electromedical devices, OR infrastructure, Regulatory affairs, Documentation, Clinical trials, Medical device approval, Product design, product development, Assembly, Labeling, Auditing, Other services, Assembly systems, Measuring technolgy, testing technology, Embedded systems, Software development
Cardiology
Here a rea few project examples from seleon in the field of ventilation.
CONTRAST MEDIUM INJECTOR FOR CT
The Contrast Medium Injector was developed by seleon for the intravenous injection of contrast media and isotonic saline solutions for computer tomography in the context of an examination with CT and CT-PET scanners.
seleon was in charge of development through all phases: from the concept to the functional models, prototypes (including approvals) to the transfer to series production. Both project management and the coordination of external project participants were handled by seleon.
With the complete development of the Contrast Medium Injector, the customer has access to seleon’s bundled know-how. The company has detailed documentation, both for matters related to development and for implementation and manufacturing. The customer obtains a high-performance, economically successful device with the best service.
STENT COATING SYSTEM
Several steps can be completed in one with the device. The protective cap is removed from the stent with the operation of the lever, and at the same time, the drug is applied and dried with sterile oxygen.
On behalf of the customer, seleon realised the development, production and servicing of the Stent Coating Machine. Numerous technical challenges were associated with this task. For example, a solution was found for the sterile fixation of the stent in the coating machine. Another important requirement was to design the cartridge in which the stent is coated as a low-cost disposable plastic component. User ergonomics, reliability and easy cleaning were other essential considerations that had to be taken into account.
The handling of quality assurance and service by seleon and the international deployment show that development and production from one source promises success.
A PHYSIOLOGICAL MEASURING MODULE FOR THE SYNCHRONISATION OF THE ECG DATA WITH THE CT SCAN
For a new generation of CT scanners, a Physiological Measurement Module (PMM) was developed and manufactured for the synchronization of CT imaging with the respiratory or heart rate of the patient.
During data acquisition with the CT scanner, the PMM has to record and analyse physiological data such as the ECG, pulse rate and a respiratory signal. A trigger signal has to be derived from the ECG data in real time, triggering the CT scan in a defined heart phase. The PMM has to be integrated into the foot of the scanner as a self-contained module.
hanks to its in-depth expertise in data analysis, seleon was able to develop a sophisticated ECG analysis procedure. Once the corresponding heart phase is identified based on the ECG data, the module sends a trigger signal to the CT scanner. This permits image capturing in the pause between two heartbeats, regardless of the heart rate or irregularities in the patient’s heartbeat.
Bundling all process steps from development to series production with one vendor and ongoing, transparent reporting to the customer led to the seamless integration of the module into the scanner. With an intelligent controller from the customer, adaptive dosage modulation controlled by the ECG was realised, minimising the radiation exposure in the fast heart movement phases.
OXIMETER FOR THE LOCAL MEASUREMENT OF OXYGEN SATURATION IN THE BLOOD
The Oximeter is a measuring device to determine the local oxygen saturation in the blood. It is used at a heart catheter measuring station. It can be used flexibly through its Bluetooth connection to the cardiac catheter measuring station. During an examination using a catheter, it determines the local oxygen saturation in the patient’s heart ventricles without drawing additional blood.
seleon was responsible for the development of the Oximeter up to series readiness of the device. Device features include a compact, robust design, minimal power consumption, wireless operation and wireless data transfer. Various operating states have to be indicated by audible signals. The measuring device has to stand up to surface disinfection.
Usability is improved in particular by the wireless technology. Thanks to wireless transmission of the automatically determined blood oxygen saturation data to the PC, there are no restrictions of movement.
THE HAEMO BASE RESEARCH PROJECT
The aim of the research project 'Haemo Base' was to develop an analysis unit to be used in a hemodynamic measurement station in the cardiac catheterization laboratory. The use of the analysis unit was planned for different scenarios:
Thanks to the detailed concept and the associated estimate of the development costs as well as the estimate of the production costs, the customer was able to decided whether to develop the complete system or purchase parts of it.
CONTRAST MEDIUM INJECTOR FOR CT
The Contrast Medium Injector was developed by seleon for the intravenous injection of contrast media and isotonic saline solutions for computer tomography in the context of an examination with CT and CT-PET scanners.
seleon was in charge of development through all phases: from the concept to the functional models, prototypes (including approvals) to the transfer to series production. Both project management and the coordination of external project participants were handled by seleon.
With the complete development of the Contrast Medium Injector, the customer has access to seleon’s bundled know-how. The company has detailed documentation, both for matters related to development and for implementation and manufacturing. The customer obtains a high-performance, economically successful device with the best service.
STENT COATING SYSTEM
Several steps can be completed in one with the device. The protective cap is removed from the stent with the operation of the lever, and at the same time, the drug is applied and dried with sterile oxygen.
On behalf of the customer, seleon realised the development, production and servicing of the Stent Coating Machine. Numerous technical challenges were associated with this task. For example, a solution was found for the sterile fixation of the stent in the coating machine. Another important requirement was to design the cartridge in which the stent is coated as a low-cost disposable plastic component. User ergonomics, reliability and easy cleaning were other essential considerations that had to be taken into account.
The handling of quality assurance and service by seleon and the international deployment show that development and production from one source promises success.
A PHYSIOLOGICAL MEASURING MODULE FOR THE SYNCHRONISATION OF THE ECG DATA WITH THE CT SCAN
For a new generation of CT scanners, a Physiological Measurement Module (PMM) was developed and manufactured for the synchronization of CT imaging with the respiratory or heart rate of the patient.
During data acquisition with the CT scanner, the PMM has to record and analyse physiological data such as the ECG, pulse rate and a respiratory signal. A trigger signal has to be derived from the ECG data in real time, triggering the CT scan in a defined heart phase. The PMM has to be integrated into the foot of the scanner as a self-contained module.
hanks to its in-depth expertise in data analysis, seleon was able to develop a sophisticated ECG analysis procedure. Once the corresponding heart phase is identified based on the ECG data, the module sends a trigger signal to the CT scanner. This permits image capturing in the pause between two heartbeats, regardless of the heart rate or irregularities in the patient’s heartbeat.
Bundling all process steps from development to series production with one vendor and ongoing, transparent reporting to the customer led to the seamless integration of the module into the scanner. With an intelligent controller from the customer, adaptive dosage modulation controlled by the ECG was realised, minimising the radiation exposure in the fast heart movement phases.
OXIMETER FOR THE LOCAL MEASUREMENT OF OXYGEN SATURATION IN THE BLOOD
The Oximeter is a measuring device to determine the local oxygen saturation in the blood. It is used at a heart catheter measuring station. It can be used flexibly through its Bluetooth connection to the cardiac catheter measuring station. During an examination using a catheter, it determines the local oxygen saturation in the patient’s heart ventricles without drawing additional blood.
seleon was responsible for the development of the Oximeter up to series readiness of the device. Device features include a compact, robust design, minimal power consumption, wireless operation and wireless data transfer. Various operating states have to be indicated by audible signals. The measuring device has to stand up to surface disinfection.
Usability is improved in particular by the wireless technology. Thanks to wireless transmission of the automatically determined blood oxygen saturation data to the PC, there are no restrictions of movement.
THE HAEMO BASE RESEARCH PROJECT
The aim of the research project 'Haemo Base' was to develop an analysis unit to be used in a hemodynamic measurement station in the cardiac catheterization laboratory. The use of the analysis unit was planned for different scenarios:
- As part of a haemodynamic measuring station in the heart catheter laboratory
- As part of a combined hybrid solution with a haemodynamic and electrophysiological diagnostics measuring station
Thanks to the detailed concept and the associated estimate of the development costs as well as the estimate of the production costs, the customer was able to decided whether to develop the complete system or purchase parts of it.
Product category: Electronics development, Rapid prototyping, Other component manufacturing, Electromedical devices, Endoscopes, OR infrastructure, Regulatory affairs, Documentation, Clinical trials, Medical device approval, Product design, product development, Assembly, Labeling, Auditing, Other services, Assembly systems, Measuring technolgy, testing technology, Embedded systems, Software development
Measurement technologies
Here are a few project examples from seleon in the field of measurement technology.
THE HAEMO BASE RESEARCH PROJECT
The aim of the research project 'Haemo Base' was to develop an analysis unit to be used in a hemodynamic measurement station in the cardiac catheterization laboratory. The use of the analysis unit was planned for different scenarios:
As part of a haemodynamic measuring station in the heart catheter laboratory
As part of a combined hybrid solution with a haemodynamic and electrophysiological diagnostics measuring station
The development has been implemented up to prototypes being produced by seleon. All documents required to prepare for and support medical approval were created. Preparations for medical approval had to be made for the potential markets of Europe, the USA/Canada and other regions.
Thanks to the detailed concept and the associated estimate of the development costs as well as the estimate of the production costs, the customer was able to decided whether to develop the complete system or purchase parts of it.
AIRSENS: MODIFIABLE PRESSURE SENSOR
Together with the HSG-IMIT, seleon gmbh has developed a new generation of flow sensors with very low flow rates and fast response.
Airsens can be used to monitor breathing in the sleep laboratory, intensive care unit or a post-surgery recovery room. Physiological harmlessness for the ventilation field has been proven. An integrated filter in combination with a pitot tube helps keep out contaminants. Breathing resistance is minimal. The patient breathes through a disposable. Thanks to pre-processing in the sensor, the data are available for direct use. This device was developed by seleon as a prototype.
SCOPE PILOT – INTERACTIVE TEST DEVICE FOR ENDOSCOPE PREPARATION
The device provides the user with standardised, interactive guidance through the endoscope preparation process. Carrying out the actions is recorded and documented. A central data storage system supports the preparation of statistics for the endoscopes and their use.
All aspects of development as well as subsequent approval of the product for the European and North American markets were assigned to seleon.
The quality of endoscope testing during preparation has been improved. With standardised, easy to follow procedures, the device guides the user and helps identify malfunctions in a timely manner before the endoscope is damaged more extensively.
Information about endoscope preparation can be viewed and analysed by the clinic and service staff in order to further optimise endoscope use.
THE HAEMO BASE RESEARCH PROJECT
The aim of the research project 'Haemo Base' was to develop an analysis unit to be used in a hemodynamic measurement station in the cardiac catheterization laboratory. The use of the analysis unit was planned for different scenarios:
As part of a haemodynamic measuring station in the heart catheter laboratory
As part of a combined hybrid solution with a haemodynamic and electrophysiological diagnostics measuring station
The development has been implemented up to prototypes being produced by seleon. All documents required to prepare for and support medical approval were created. Preparations for medical approval had to be made for the potential markets of Europe, the USA/Canada and other regions.
Thanks to the detailed concept and the associated estimate of the development costs as well as the estimate of the production costs, the customer was able to decided whether to develop the complete system or purchase parts of it.
AIRSENS: MODIFIABLE PRESSURE SENSOR
Together with the HSG-IMIT, seleon gmbh has developed a new generation of flow sensors with very low flow rates and fast response.
Airsens can be used to monitor breathing in the sleep laboratory, intensive care unit or a post-surgery recovery room. Physiological harmlessness for the ventilation field has been proven. An integrated filter in combination with a pitot tube helps keep out contaminants. Breathing resistance is minimal. The patient breathes through a disposable. Thanks to pre-processing in the sensor, the data are available for direct use. This device was developed by seleon as a prototype.
SCOPE PILOT – INTERACTIVE TEST DEVICE FOR ENDOSCOPE PREPARATION
The device provides the user with standardised, interactive guidance through the endoscope preparation process. Carrying out the actions is recorded and documented. A central data storage system supports the preparation of statistics for the endoscopes and their use.
All aspects of development as well as subsequent approval of the product for the European and North American markets were assigned to seleon.
The quality of endoscope testing during preparation has been improved. With standardised, easy to follow procedures, the device guides the user and helps identify malfunctions in a timely manner before the endoscope is damaged more extensively.
Information about endoscope preparation can be viewed and analysed by the clinic and service staff in order to further optimise endoscope use.
Product category: Electronics development, Rapid prototyping, Other component manufacturing, Electromedical devices, OR infrastructure, Regulatory affairs, Documentation, Clinical trials, Medical device approval, Product design, product development, Assembly, Labeling, Auditing, Other services, Assembly systems, Measuring technolgy, testing technology, Embedded systems, Software development
Diagnostic
Here a rea few project examples from seleon in the field of diagnostic.
A PHYSIOLOGICAL MEASURING MODULE FOR THE SYNCHRONISATION OF THE ECG DATA WITH THE CT SCAN
For a new generation of CT scanners, a Physiological Measurement Module (PMM) was developed and manufactured for the synchronization of CT imaging with the respiratory or heart rate of the patient.
During data acquisition with the CT scanner, the PMM has to record and analyse physiological data such as the ECG, pulse rate and a respiratory signal. A trigger signal has to be derived from the ECG data in real time, triggering the CT scan in a defined heart phase. The PMM has to be integrated into the foot of the scanner as a self-contained module.
hanks to its in-depth expertise in data analysis, seleon was able to develop a sophisticated ECG analysis procedure. Once the corresponding heart phase is identified based on the ECG data, the module sends a trigger signal to the CT scanner. This permits image capturing in the pause between two heartbeats, regardless of the heart rate or irregularities in the patient’s heartbeat.
Bundling all process steps from development to series production with one vendor and ongoing, transparent reporting to the customer led to the seamless integration of the module into the scanner. With an intelligent controller from the customer, adaptive dosage modulation controlled by the ECG was realised, minimising the radiation exposure in the fast heart movement phases.
THE HAEMO BASE RESEARCH PROJECT
The aim of the research project 'Haemo Base' was to develop an analysis unit to be used in a hemodynamic measurement station in the cardiac catheterization laboratory. The use of the analysis unit was planned for different scenarios:
As part of a haemodynamic measuring station in the heart catheter laboratory
As part of a combined hybrid solution with a haemodynamic and electrophysiological diagnostics measuring station
The development has been implemented up to prototypes being produced by seleon. All documents required to prepare for and support medical approval were created. Preparations for medical approval had to be made for the potential markets of Europe, the USA/Canada and other regions.
Thanks to the detailed concept and the associated estimate of the development costs as well as the estimate of the production costs, the customer was able to decided whether to develop the complete system or purchase parts of it.
SPECIMEN HANDLING ROBOT
The performance and capacity of a robot that transports test tubes were tested using a functional model of the robot. Costs and the technology were optimised using a subsequent functional model.
The functional model was built by seleon in six months using standard components. In regards to the mechanical systems, controller development, communication with other devices and cost reductions, the entire task was completed on time. The optimised second functional model is available to the customer for studies.
The first functional model confirmed the feasibility of the project. It was revised to reduce costs and improve the functionality. Now the functional model serves as the foundation for the feasibility study within the overall system for the project.
AIRTRUST® MED – AIR COMPRESSOR
The airtrust® med is a quiet, compact and powerful air compressor intended to supply clinical ventilators with clean, high quality compressed air.
Due to the combination of proven compressor technology, robust controls and minimal maintenance requirements, the airtrust® med is a reliable piece of equipment for everyday clinical use or in areas where the compressed air supply is missing or unreliable.
The airtrust® med starts up automatically if the pressure of the central compressed air supply drops below a specified value or if a medical compressed air supply is generally unavailable.
Two versions of the compressor are available. The airtrust® med dry features an additional membrane dryer, therefore allowing for the use of high humidity ambient air or if the air supply must meet special requirements.
Even for small production runs, the OEM compressor can be modified to meet special customer-specific requirements. Customer requirements can be implemented quickly and easily through elements such as the modular firmware concept, the graphical user interface, and an extendible pressure range. Additional interface languages or a customer-specific design are easy to implement.
A PHYSIOLOGICAL MEASURING MODULE FOR THE SYNCHRONISATION OF THE ECG DATA WITH THE CT SCAN
For a new generation of CT scanners, a Physiological Measurement Module (PMM) was developed and manufactured for the synchronization of CT imaging with the respiratory or heart rate of the patient.
During data acquisition with the CT scanner, the PMM has to record and analyse physiological data such as the ECG, pulse rate and a respiratory signal. A trigger signal has to be derived from the ECG data in real time, triggering the CT scan in a defined heart phase. The PMM has to be integrated into the foot of the scanner as a self-contained module.
hanks to its in-depth expertise in data analysis, seleon was able to develop a sophisticated ECG analysis procedure. Once the corresponding heart phase is identified based on the ECG data, the module sends a trigger signal to the CT scanner. This permits image capturing in the pause between two heartbeats, regardless of the heart rate or irregularities in the patient’s heartbeat.
Bundling all process steps from development to series production with one vendor and ongoing, transparent reporting to the customer led to the seamless integration of the module into the scanner. With an intelligent controller from the customer, adaptive dosage modulation controlled by the ECG was realised, minimising the radiation exposure in the fast heart movement phases.
THE HAEMO BASE RESEARCH PROJECT
The aim of the research project 'Haemo Base' was to develop an analysis unit to be used in a hemodynamic measurement station in the cardiac catheterization laboratory. The use of the analysis unit was planned for different scenarios:
As part of a haemodynamic measuring station in the heart catheter laboratory
As part of a combined hybrid solution with a haemodynamic and electrophysiological diagnostics measuring station
The development has been implemented up to prototypes being produced by seleon. All documents required to prepare for and support medical approval were created. Preparations for medical approval had to be made for the potential markets of Europe, the USA/Canada and other regions.
Thanks to the detailed concept and the associated estimate of the development costs as well as the estimate of the production costs, the customer was able to decided whether to develop the complete system or purchase parts of it.
SPECIMEN HANDLING ROBOT
The performance and capacity of a robot that transports test tubes were tested using a functional model of the robot. Costs and the technology were optimised using a subsequent functional model.
The functional model was built by seleon in six months using standard components. In regards to the mechanical systems, controller development, communication with other devices and cost reductions, the entire task was completed on time. The optimised second functional model is available to the customer for studies.
The first functional model confirmed the feasibility of the project. It was revised to reduce costs and improve the functionality. Now the functional model serves as the foundation for the feasibility study within the overall system for the project.
AIRTRUST® MED – AIR COMPRESSOR
The airtrust® med is a quiet, compact and powerful air compressor intended to supply clinical ventilators with clean, high quality compressed air.
Due to the combination of proven compressor technology, robust controls and minimal maintenance requirements, the airtrust® med is a reliable piece of equipment for everyday clinical use or in areas where the compressed air supply is missing or unreliable.
The airtrust® med starts up automatically if the pressure of the central compressed air supply drops below a specified value or if a medical compressed air supply is generally unavailable.
Two versions of the compressor are available. The airtrust® med dry features an additional membrane dryer, therefore allowing for the use of high humidity ambient air or if the air supply must meet special requirements.
Even for small production runs, the OEM compressor can be modified to meet special customer-specific requirements. Customer requirements can be implemented quickly and easily through elements such as the modular firmware concept, the graphical user interface, and an extendible pressure range. Additional interface languages or a customer-specific design are easy to implement.
Company news
Date
Topic
09 Nov 2020
RISK MANAGEMENT STANDARD FOR MEDICAL PRODUCTS. WHICH WAY IS THE WIND BLOWING?
Seeing which way the wind is blowing means being able to recognise developments and adapt to necessary changes. ISO 14971:2019, the risk management standard for medical devices, published in its third version in December 2019, is a good opportunity to see what has happened since then. First things first: The risk management standard for medical devices ISO 14971:2019 has not yet been harmonised for MDR, but there is an up-to-date guide for its implementation.
seleon's experts summarise the most important points of the guide and from an MDR perspective for the risk management standard ISO 14971:2019-12 and point out discrepancies in harmonisation in their Regulatory Affairs Blog.
seleon's experts summarise the most important points of the guide and from an MDR perspective for the risk management standard ISO 14971:2019-12 and point out discrepancies in harmonisation in their Regulatory Affairs Blog.
04 Nov 2020
WHO AM I? IMPORTER? MANUFACTURER? DISTRIBUTOR? Article 13 of the MDR brings light into the dark regarding importers
For importers of medical devices the following instructions apply: Check. Report. Cooperate. And be jointly and severally liable when the going gets tough, one might add. But enough of the guessing game about who will take over the responsibilities of the distributor, manufacturer and/or importer. seleon’s list details and describes tasks and consequences for the species mentioned.
The Regulatory Affairs Blog of seleon gets down to business!
The Regulatory Affairs Blog of seleon gets down to business!
14 Oct 2020
WITHOUT DIGA IT WONT DO...
The regular grab for or glance at your smartphone shows that almost nothing works without digital apps. And this does not only affect young people. The current tense situation due to the pandemic situation is bringing the advantages of digital innovation in the medical sector to light. A visit to the doctor is no longer necessary because you can talk to the doctor via smartphone or PC; health apps on the smartphone collect health-related data, evaluate it and forward it to the doctor for further treatment. The digital devices are motivator, evaluator and tipster in one. They do not replace communication between patients and doctors, but they make it easier, save time, ways and costs, in short: the digital change in medicine is unstoppable.
Soon, even doctors will be able to prescribe apps on prescription, with the cost of these being covered by health insurance.
In order to strengthen digitisation in medicine, the German Federal Government has introduced some new legal regulations:
Soon, even doctors will be able to prescribe apps on prescription, with the cost of these being covered by health insurance.
In order to strengthen digitisation in medicine, the German Federal Government has introduced some new legal regulations:
- Law for better coverage through digitisation and innovation (“Gesetz für eine bessere Versorgung durch Digitalisierung und Innovation“)
(Digital Supply Act - Digitale Versorgungs Gesetz - DVG) came into force on 19 December 2019 - Regulation on the procedure and requirements for testing the eligibility of digital health applications for reimbursement by the statutory health insurance scheme (“Verordnung über das Verfahren und die Anforderungen zur Prüfung der Erstattungsfähigkeit digitaler Gesundheitsanwendungen in der gesetzlichen Krankenversicherung”)
(Digital Health Applications Regulation - Digitale-Gesundheitsanwendungen-Verordnung - DiGAV)
14 Oct 2020
Australian Excellence - A Model for Europe?
It is always an advantage to look beyond your own nose. And not only beyond the borders of Europe, but far away - as far as Australia. The continent prides itself on its excellent healthcare system and considers itself well equipped to deal with the consequences of a growing population. We want to know more about it. What do Australians do differently or better than we do in Europe?
The regulatory body
The regulatory authority is the Therapeutic Goods Administration (TGA), it is part of the Australian Government Department for Health and Ageing. The TGA is also the conformity assessment body for Australian manufacturers and some foreign sites. In general, the Australian regulatory system is a combination of GHTF (Global Harmonisation Task Force) and European elements by leveraging Notified Body issued CE marking certificates and the enforced control by TGA. The system is therefore largely based on the GHTF principles. Before a medical device can be marketed in Australia, an Australian Register of Therapeutic Goods (ARTG) listing number needs to be assigned. The Global Medical Device Nomenclature (GMDN) Codes are required with the ARTG listings.
The Australian regulatory system is formally based on the European regulatory system. Medical devices including IVD devices are assessed against the Essential Principles and in line with their intended purpose and risk-based classification. The regulatory framework for medical devices spans the life of the device and includes:
The regulatory body
The regulatory authority is the Therapeutic Goods Administration (TGA), it is part of the Australian Government Department for Health and Ageing. The TGA is also the conformity assessment body for Australian manufacturers and some foreign sites. In general, the Australian regulatory system is a combination of GHTF (Global Harmonisation Task Force) and European elements by leveraging Notified Body issued CE marking certificates and the enforced control by TGA. The system is therefore largely based on the GHTF principles. Before a medical device can be marketed in Australia, an Australian Register of Therapeutic Goods (ARTG) listing number needs to be assigned. The Global Medical Device Nomenclature (GMDN) Codes are required with the ARTG listings.
The Australian regulatory system is formally based on the European regulatory system. Medical devices including IVD devices are assessed against the Essential Principles and in line with their intended purpose and risk-based classification. The regulatory framework for medical devices spans the life of the device and includes:
- Pre-market assessment: conformity assessment
- Market authorisation: inclusion in the ARTG
- Post-market monitoring: continuing compliance with all regulatory, safety and performance requirements and standards.
About us
Company portrait
seleon gmbh has been one of the leading development, consulting and production service providers in medical technology for over 20 years.
We support start-ups, small and medium-sized companies as well as corporations with their active and non-active medical devices, in-vitro diagnostics and drug-device combination products.
In our One Stop Shop we offer you solutions tailored to your requirements
already in the discovery phase concept workshops on product definition, market access, clinical & regulatory strategy and reimbursement topics
in the development of medical devices, medical software and medical apps,
with Regulatory Affairs in the creation and maintenance of technical documentation and international product approvals
with Clinical Affairs in the preparation of clinical evaluations and conduct of clinical trials,
in quality and process management,
in the production transfer of medical products developed by you, us or third parties,
during ramp-up and series production
for market placement and reimbursement issues and
in change management and product maintenance.
You can find further information on our website www.seleon.de.
We regularly publish interesting knowledge-based articles on current regulatory topics free of charge on our second website www.regulatory-affairs.org.
We support start-ups, small and medium-sized companies as well as corporations with their active and non-active medical devices, in-vitro diagnostics and drug-device combination products.
In our One Stop Shop we offer you solutions tailored to your requirements
already in the discovery phase concept workshops on product definition, market access, clinical & regulatory strategy and reimbursement topics
in the development of medical devices, medical software and medical apps,
with Regulatory Affairs in the creation and maintenance of technical documentation and international product approvals
with Clinical Affairs in the preparation of clinical evaluations and conduct of clinical trials,
in quality and process management,
in the production transfer of medical products developed by you, us or third parties,
during ramp-up and series production
for market placement and reimbursement issues and
in change management and product maintenance.
You can find further information on our website www.seleon.de.
We regularly publish interesting knowledge-based articles on current regulatory topics free of charge on our second website www.regulatory-affairs.org.
Company data
Sales volume
10-49 Mio US $
Number of employees
100-499
Foundation
1994
Area of business
- Electrical and electronic components
- Equipment and technologies for laboratories and manufacturing
- Manufacturing Services
- Services
