Regulatory approval

Company

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.

Competence area

• Regulatory Affairs

Project tasks

• 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

Project duration

• 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.