Regulatory & Quality.

Regulatory

We provide support for

  • Label content
  • CE- and FDA Registration
  • Country registrations / Product approval
  • Canadian Licensing
  • PMA Submissions
  • Pre-market Notifications

Komet Medical can offer fully documented and approved medical devices according to EU-MDR and FDA on a private label basis. Furthermore, full support is provided for the corresponding country registration.

Quality

We support the set-up and updates of the technical file

  • FMEAs
  • Risk management / Hazard list / Biocompability
  • Verification & Validation
  • Process validation for all special processes (electropolishing, hardening, passivation, cleaning, packaging, ...)
  • Cleaning validation
  • Packaging validation
  • Statistical process control (SPC/CAQ) 
  • CAD/CAM

We are certified according to

  • ISO-13485:2016 (MDSAP)
  • EN ISO-13485:2016
  • ISO-9001:2015
  • Directive 93/42/EEC and AEO

Certificates

Get in Contact

Product

Contract Manufacturing
Rechtliches
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Komet Medical is not only a contract manufacturer. Komet Medical offers on request a fully approved medical device based on EU-MDR and FDA requirements - on a private label basis. Our customer receives the required product with his order number system and with packaging in his corporate design. However, Komet Medical takes over the role of Legal Manufacturer with all rights and obligations as well as full support for the country registrations.

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