I will review medical device mdr technical documentation

I have more than 10 years of experience in the medical device industry, working on both the manufacturer side and the notified body side. This experience gives me a strong understanding of how technical documentation is assessed during conformity assessment under EU MDR.

In this service, I will review your medical device technical documentation from a regulatory perspective and identify potential gaps, inconsistencies, or areas that may require improvement before submission.

This review can include documents such as:

• Clinical Evaluation (CEP, CER, SSCP)
• PMS and PMCF documentation
• Risk management documentation
• EU MDR technical documentation structure

You will receive structured feedback highlighting potential regulatory risks and suggestions for improvement to help strengthen your documentation.

This service is suitable for manufacturers, startups, and regulatory teams preparing documentation for EU MDR compliance.