The customer is one of the leading international manufacturers of products for medical eye surgery. A special focus is on the area of ocular implants.
- Regulatory Affairs
- Control of global RA management (CE (EU), 510(k) (US), PMA (US), CMDCAS, SOR92 (CAN), China, Taiwan, Japan, Australia, New Zealand, Latin America, Middle East, Russia, CIP states, BRIC states).
- Reprocessing of technical documentation
- Compatibility test along the standard ISO 10993-x
- Control of CRO activities
- Clinical evaluation according to MEDDEV 2.7.1
- 5 months
We would be happy to compile further project references for you on request. Just let us know what exactly interests you. We will get back to you as soon as possible.
Regulatory approval of class II and III medical devices
segment: medical remanufacturing procedure
Validation and documentation of development processes
Segment: adaptive radiotherapy