Mechatronic AG of Darmstadt at COMPAMED 2017 in Düsseldorf -- COMPAMED Trade Fair
Manufacturers Service

Mechatronic AG

Wittichstr. 2, 64295 Darmstadt
Germany

Telephone +49 6151 5003-0
Fax +49 6151 5003-170
mechatronic@mechatronic.de

Hall map

COMPAMED 2017 hall map (Hall 8b): stand H03

Fairground map

COMPAMED 2017 fairground map: Hall 8b

Contact

Karl Wörtche

Head of Sales

Wittichstraße 2
64295 Darmstadt

Phone
06151 - 5003-0

Email
karl.woertche@mechatronic.de

Marius Felling

Sales Manager

Wittichstraße 2
64295 Darmstadt

Phone
06151-5003-0

Email
marius.felling@mechatronic.de

Claudia Bernhart

Sales Manager

Wittichstraße 2
64295 Darmstadt

Phone
06151-5003-0

Email
claudia.bernhart@mechatronic.de

Ricarda Groß

Manager Corp. Communications & Sales Operations

Wittichstraße 2
64295 Darmstadt

Phone
06151-5003-0

Email
ricarda.gross@mechatronic.de

Our range of products

Product categories

  • 10  Equipment and technologies for laboratories and manufacturing
  • 10.02  Manufacturing equipment
  • 10.02.02  Automation systems
  • 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
  • 11.16.13  Assembly
  • 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
  • 13.01.06  Electrical systems, subassemblies

Electrical systems, subassemblies

  • 13  Services
  • 13.01  Design, Research and Development Services
  • 13.01.15  Product design and development

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
  • 13.02.04  Testing equipment
  • 13  Services
  • 13.02  Testing, certification, quality assurance
  • 13.02.08  Quality assurance, quality systems
  • 13  Services
  • 13.03  Consultants
  • 13.03.07  Risk management
  • 13  Services
  • 13.03  Consultants
  • 13.03.10  Registration, submission assistance

Registration, submission assistance

  • 13  Services
  • 13.03  Consultants
  • 13.03.14  Technical documentation

Our products

Product category: Engineering, Embedded systems, Design engineering, Product design and development, Programmable electrical medical systems, Prototyping, Testing equipment, Risk management, Registration, submission assistance, Technical documentation, Automation systems, Electronic systems / subassemblies, Electrical systems, subassemblies

Development

We give your requirements form and function. More than 40 experts in software, electronics, measurement technology and mechanics develop your product with the latest tools, from a digital 3D model to a fully functional prototype. Structured project and risk management is the basis for rapid results.
Our development methodologies do not just fulfill the technical requirements and comply with the standards – we create them.

Predevelopement
- Product conception / system concepts
- Project strategy
- Proof of Concepts / feasibility study
- Requirement analysis
- Selection of technology

Product Development
- Compliance with standards
- System modeling (SysML)
- Electronic, software and mechanical design
- Validation and verification
- Design for X (cost, manufacturing, testability)
- Risk management process

Quality standards
Mechatronic’s quality management system is certified according to DIN EN ISO 9001:2008 and DIN EN ISO 13485:2012.
Mechatronic AG is also FDA accepted and CSA controlled.

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Product category: Assembly, High end assembly, Production engineering, medical systems, Electronic systems / subassemblies, Electrical systems, subassemblies

Series Production

We see ourselves as a full-service manufacturer for small to medium-sized batches. We are a dependable and skilled partner, producing electronic and electromechanical components as well as measuring and control instruments for diagnosis and treatment. In doing so, we implement all the principles of good manufacturing practice, or GMP, from the international standard for the production of medical products. We offer the following services:

Transition to series production
- Setup of assembly and test lines (conceptual design, development, implementing)
- Supplier management
- Process qualifications (IQ, OQ, PQ)
- Cost and product optimisation
- Sampling inspection
- Change managementSetup of assembly and test lines
    (conceptual design, development, implementing)

Series Production
- Global Sourcing
- High-End-Assembly / Construction: Components / Devices
- In-Circuit-Test (incl. Components programming)
- Functional test:   manually /  automated
- Batch tracking
- Documented manufacturing
- Logistics

After-sales
We also take care of providing after-sales product support for our customers:
- Repair and warranty services
- Fault diagnostics, functional and system tests
- Product maintenance: update, upgrade, redesign
- Obsolete component management
- Component and spare part supply

Quality standards
Mechatronic’s quality management system is certified according to DIN EN ISO 9001:2008 and DIN EN ISO 13485:2012.
Mechatronic AG is also FDA accepted and CSA controlled.

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Product category: Quality assurance, quality systems, Risk management, Registration, submission assistance, Technical documentation

Consulting and approval support

We will assist you in obtaining national and international approval for medical devices and with processes such as CE, CB, 510(k), PMA, de novo and CFDA requirements. We offer expert support for your risk analysis and FMEA and will be there for you as you set up and develop your quality management system.

In addition to issues concerning approval and documentation, we are also the ideal source of advice on many other matters, such as assessing whether your project is actually realistic and what the costs will be, or if you need a second opinion on a project that is already under way.

Our team can also provide you with expert assistance in choosing a suitable OEM supplier.

- Classification of medical devices in accordance with Annex 9 of Directive 93/42/EEC
- Technical risk management as per DIN EN ISO 14971
- Preparation of technical documentation in accordance with standards, as specified by Directive 93/42/EEC or e.g. for a 510(k) clearance
- Set-up of the product file or DMR
- Support in setting up the risk management file
- Support in setting up and developing the quality management system
- FMEA and risk analysis
- Technical due diligence
- Assistance with clinical evaluation

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Product category: Automation systems, Testing equipment, Quality assurance, quality systems

Automated Test Equipment

Automated test equipment
We provide test equipment for quality assurance and batch production of modules and devices. Our internationally installed and approved modular ATE system integrates measurement technology for electrical and mechanical parameters, programming, calibration, final testing and the corresponding data management.

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About us

Company details

Mechatronic AG is an international specialist in the development and production of medical devices and the provision of services, software products and test equipment in the field of medical technology. Since 1987, the company has been developing and manufacturing medical technology components and products on behalf of its customers. Start-ups as well as large corporations can rely on its long-standing experience in the industry, extensive expertise regarding processes and methods and “Made in Germany” product development and manufacturing. Its portfolio ranges from new developments and the redesign of existing products to individual service modules. In addition to this, the company offers test systems for series production and consulting in the area of product approval. From the initial idea to the after-sales service, Mechatronic AG offers expert technical solutions, thereby bringing the ideas of its customers to maturity quickly and reliably. The accompanying documentation satisfies FDA and CE requirements.

The following organizations perform regularly inspections: TÜV, FDA, ANVISA, UL, CSA, INMETRO. Mechatronic AG, certified in accordance with DIN EN ISO 9001 and DIN EN ISO 13485, is headquartered in Darmstadt, Germany.

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Company data

Sales volume

10-49 Mio US $

Number of employees

50-99

Foundation

1987

Area of business
  • Manufacturing Services
  • Services