seleon gmbh of Heilbronn at COMPAMED 2017 in Düsseldorf -- COMPAMED Trade Fair
Manufacturers Service

seleon gmbh

Im Zukunftspark 1, 74076 Heilbronn
Germany

Telephone +49 7131 2774-0
Fax +49 7131 2774-100
info@seleon.de

Hall map

COMPAMED 2017 hall map (Hall 8b): stand A16

Fairground map

COMPAMED 2017 fairground map: Hall 8b

Contact

Fabiola Hartung-Linz

Projektadministration & Marketing

Im Zukunftspark 1
74076 Heilbronn

Phone
+49 (0)7131 2774-40
+49 171 568 05 48

Email
fabiola.hartung-linz@seleon.de

Dipl. Ing. Andreas Happold, MBA

Sales Director

Im Zukunftspark 1
74072 Heilbronn

Phone
+49 7131 2774 37
+49 171 228 55 32

Email
andreas.happold@seleon.de

Dipl.-Phys. Dr. Stefan Fiedler

Director Business Development

Im Zukunftspark 1
74076 Heilbronn

Phone
+49 7131 2774 47
+49 160 983 235 04

Email
stefan.fiedler@seleon.de

Our range of products

Product categories

  • 01  Components, parts, modules, Original Equipment Manufacturers
  • 01.10  Computing, Software

Computing, Software

  • 10  Equipment and technologies for laboratories and manufacturing
  • 10.02  Manufacturing equipment
  • 10.02.12  Engineering

Engineering

  • 11  Manufacturing Services
  • 11.12  Electronic systems / subassemblies

Electronic systems / subassemblies

  • 11  Manufacturing Services
  • 11.16  Forming
  • 11.16.14  High end assembly

High end assembly

  • 11  Manufacturing Services
  • 11.16  Forming
  • 11.16.25  Production engineering, medical systems

Production engineering, medical systems

  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.04  Embedded systems

Embedded systems

  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.05  Design engineering

Design engineering

  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.15  Product design and development
  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.16  Programmable electrical medical systems

Programmable electrical medical systems

  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.17  Prototyping

Prototyping

  • 13  Services
  • 13.02  Testing, certification, quality assurance
  • 13.02.01  Auditing, inspections

Auditing, inspections

  • 13  Services
  • 13.02  Testing, certification, quality assurance
  • 13.02.02  European "Medical Device Directive" 93/42 conformity assessment services

European "Medical Device Directive" 93/42 conformity assessment services

  • 13  Services
  • 13.02  Testing, certification, quality assurance
  • 13.02.04  Testing equipment

Testing equipment

  • 13  Services
  • 13.02  Testing, certification, quality assurance
  • 13.02.08  Quality assurance, quality systems

Quality assurance, quality systems

  • 13  Services
  • 13.03  Consultants
  • 13.03.07  Risk management

Risk management

  • 13  Services
  • 13.03  Consultants
  • 13.03.10  Registration, submission assistance

Registration, submission assistance

  • 13  Services
  • 13.03  Consultants
  • 13.03.12  Clinical assessment and clinical trials management

Clinical assessment and clinical trials management

  • 13  Services
  • 13.03  Consultants
  • 13.03.13  Training services

Training services

  • 13  Services
  • 13.03  Consultants
  • 13.03.14  Technical documentation

Technical documentation

Our products

Product category: Computing, Software

SOFTWARE/FIRMWARE

seleon gmbh offers professional services in the development of software and firmware for medical devices. We prepare individual solutions for all common hardware and software platforms, tailored to the needs of the respective customer.

In addition to conceptual design, realisation, testing and documentation, we are also happy to look after commissioning and subsequent product support by request. Approval processes are extensively prepared and effectively managed by us in cooperation with you.

The spectrum ranges from simple device control on a microcontroller basis to complex embedded systems to multiprocessor systems for life-sustaining or safety-related applications. We also develop appealing, especially optimised user interfaces as well as operating workflows along with the adaptation and integration of real-time operating systems.

The connection of external PCs and servers as well as mobile devices completes our offering.

The seamless integration of the software and product development processes is consistently guaranteed. Taking into account the interfaces to system engineering, hardware development, risk management and quality management, and the integration of the corresponding activities, all contribute to the high quality of our software.

Our software development process implements the requirements of IEC 62304 and the FDA for the development of software for medical devices. The documentation for the medical device meets the requirements of the applicable standards and regulations.

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Product category: Product design and development

THE PERFECTION OF MEDICAL TECHNOLOGY

THE PERFECTION OF MEDICAL TECHNOLOGY
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. The immediate physical proximity to and close cooperation with our in-house development department is invaluable for our customers. Individual specifications, change requests at short notice and internal communication are possible at any time. Efficient communication helps us realise synergies for the benefit of our customers.

At seleon, everything is available at one site and from one source:
  • Means of production
  • Production and test equipment
  • Testing software
In cooperating with our partners, we can develop the product for you, assist you with development or you can handle development yourself. Our many years of experience, optimised processes that are reviewed annually, and a team of competent, highly motivated employees ensure that your product is manufactured by us in the best quality and at the best economic terms. Our success confirms that seleon has theoretical and practical know-how that is unique in the medical technology sector.

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Product category: Quality assurance, quality systems

QUALITY MANAGEMENT CONSULTING

Our business activities include:

  • Setting up QM systems
  • Conducting internal or supplier audits
  • Preparing for and supporting audits and inspections
  • Expert opinions on and evaluations of products and processes
  • Training for process, quality and regulatory matters
We are happy to provide you with an individual quotation for other topics of interest to you.

Setting up QM systems
Benefit from our many years of experience with the implementation of efficient QM systems that meet all mandatory regulatory requirements:

  • Setup of a QM system tailored to your needs in accordance with EN ISO 9001, EN ISO 13485, 21 CFR 820 and/or the medical device directives
  • Implementation of all processes required for development, production and marketing
  • Training for the new QM system
  • Coaching in the introduction phase
  • Support for internal audits and management reviews
  • Accompanying certification audits
  • Long-term support for the establishment and optimisation of your QM system

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Product category: Product design and development

MECHANICS, MECHATRONICS, & DESIGN

Our core competencies include the interaction of mechanical, electronic and information technology modules in mechatronic systems. 

We design components made of plastic and metal in ProEngineer and SolidWorks, and also organise prototyping and the production of series tooling.

Application examples:
  • Equipment technology
  • Housing design
  • Mechanical and mechatronic assemblies
  • Actuating elements, small drives and positioning
  • Precision mechanics
  • Development of special fans and blowers
  • Fixture construction

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Product category: Registration, submission assistance

APPROVAL CONSULTING (REGULATORY AFFAIRS)

Our business activities include:

  • Adaptation of products to changed regulatory requirements 
  • Preparation and maintenance of technical documentation
  • Pre-clinical and clinical evaluations
  • Clinical tests and studies
  • European and international approval of medical devices
  • Market surveillance, vigilance, post-market clinical follow-up
  • FDA approvals and coaching
We are happy to provide you with an individual quotation for other topics of interest to you.

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About us

Company details

ABOUT SELEON
seleon gmbh has been developing and producing complex equipment for customers in the medical technology field since 1998, growing into a leading medical technology service provider. We develop individual solutions in partnership with our customers around the world, quickly leading to success. With our team of experienced physicists, engineers, computer scientists, process engineers and consultants, every one of our projects reaffirms our ambition to find innovative solutions and help our customers succeed in the market.

From the idea to development and approval to series production – everything from one source – made in Germany.

COMPETENCE³
The combination of different technologies is a key characteristic of medical devices. Knowledge of these systems forms our foundation for the broad range of projects we and our customers are proud to look back on. We have already realised more than 200 projects with our customers and submitted 70 patents since the founding of our company.

Our core competencies lie in these three business areas:

  • Product development for complex medical technology systems
  • Production of medical devices according to international standards
  • Consulting for all regulatory matters related to development, international approvals and company certifications
QUALITY STANDARDS
seleon has over 85 highly qualified and motivated employees who actively implement the quality processes pursuant to DIN EN ISO 13485 and DIN EN ISO 9001. Quality is our top priority. seleon has many years of experience in the medical technology sector, with comprehensive process and methodology know-how.

With ISO 9001 and EN ISO 13485 certification, seleon gmbh applies national and international quality standards in the development of new technology solutions.

  • Testing and practical realisation of individual customer specifications in compliance with common quality standards, in-house testing
  • Transparent processes
  • Partner for external approval and certification processes

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Company data

Sales volume

10-49 Mio US $

Export content

max. 10%

Number of employees

100-499

Foundation

1998

Area of business
  • Manufacturing Services
  • Services