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
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