Medra Pte Ltd
Medra+ is a Regulatory Affairs, QA and Clinical Affairs consultancy firm, with proven expertise and skills for the last 20 years in the field of Global Regulatory Affairs of medical devices, IVD’s, drugs & pharmaceutical products and cosmetics. We assist in Design & Development, ISO 13485, QMS Compliance, Technical file writing including CER writing, 510k submissions, CE (MDR/IVDR) approval arrangement and Asia registrations. Our goal is to help our clients to achieve their sales in a very cost-effective way by integrating and understanding of international regulatory requirements. We are specialized in QA, Regulatory Strategy and Clinical Affairs consultancy.
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