Regulatory & Quality.


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.


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) 

We are certified according to

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


Get in Contact


Contract Manufacturing
read and understood the data privacy statement and noted the obligation to provide information pursuant to art. 13 of the General Data Protection Regulation. Whenever you are requested to disclose personal data while using our website, all mandatory fields are marked with an asterisk in the corresponding input mask. All other fields are optional and the information can be disclosed voluntarily.

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.

Diese Website nutzt Cookies. Wir möchten Ihnen den bestmöglichen Service bieten, dazu speichern wir Informationen über Ihren Besuch in sogenannten Cookies. Durch die Nutzung dieser Internetseite erklären Sie sich mit der Verwendung von Cookies einverstanden. Weitere Informationen entnehmen Sie bitte unserer Datenschutzerklärung. Mehr InfosEinverstanden