We help medical device manufacturers achieve MDR 2017/745 compliance by preparing Clinical Evaluation documentation (CEP, CER, PMCF, PSUR).

Our goal is to deliver documentation that is fully compliant, scientifically sound, and ready to meet Notified Body expectations – saving you time and reducing the risk of costly revisions.

What we do:

-Clinical Evaluation Plans and Reports (CEP, CER)
-Updates and MDR transition support
-Systematic literature reviews and clinical data analysis
-PMCF Plans/Reports and PSUR contributions
-Medical Writing for regulatory submissions and promotional materials

With hands-on experience and regulatory insight, we make the Clinical Evaluation process structured, reliable, and efficient.

👉 Contact us to discuss how we can support your next MDR project.

CERdev - Clinical Evaluation & MDR Compliance

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CERdev - Clinical Evaluation & MDR Compliance

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Teams

Offices

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