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
