RegPak BioPharma Consulting

EU MDR IVDR Clinical Evaluation

RegPak BioPharma Consulting is a regulatory consultancy with offices in Bucharest and Amsterdam. Its medical device practice supports EU MDR and IVDR authorised-representative obligations, technical-documentation review, declarations of conformity, clinical evaluation planning, quality systems and post-market compliance. The team also helps manufacturers prepare for notified body and regulatory audits, combining representation with operational regulatory and quality support across the device lifecycle.

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Getting Started

EU MDR: Step-By-Step Guide To Becoming Compliant

Updated 9 months ago

Dr. Oliver Eidel

3:06

Free MDR Templates

Dr. Oliver Eidel

103 views · over 2 years ago

List of Medical Device Consultants

Sven Piechottka

updated over 2 years ago