DeutschMedical Engineering
Approvals
Thoroughness, Expertise, Standards
Aside from professionalism and exceptional expertise, the development and production of medical products also requires the fulfilment of international standards. Thanks to our certified processes, you can even have our components approved under your own name. With the help of our CE- and FDA-compliant development documentation you can incorporate the necessary documents directly into your device master records.
We satisfy a whole series of standards and possess a variety of certifications. We can thus guarantee in-house development and production to your high quality standards at any time, with verifiable results.
Aside from professionalism and exceptional expertise, the development and production of medical products also requires the fulfilment of international standards. Thanks to our certified processes, you can even have our components approved under your own name. With the help of our CE- and FDA-compliant development documentation you can incorporate the necessary documents directly into your device master records.
We satisfy a whole series of standards and possess a variety of certifications. We can thus guarantee in-house development and production to your high quality standards at any time, with verifiable results.
- Development to IEC 60601 3rd ed. for medical equipment
- Risk management to DIN EN ISO 14971
- Software life cycle to IEC 62304
- Usability to IEC 62366
- CE- and FDA-compliant development documentation
- Device Master Record/Device History File
- Verification
- cGMP
- Quality management to DIN EN ISO 13485
