Course Description:
The course provides detailed insight into clinical investigation reviews for both the CE-Mark and post-market surveillance program. It particularly focuses on the aspects of clinical investigation reviews that notified bodies and regulatory authority reviewers pay attention to during the reviewing process.
This course complies with the requirements of the EU Medical Device Regulations, MEDDEV 2.7.1, MEDDEV 2.7.1, ISO 14155 as well as the NBOG checklist for auditing clinical investigations.
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