Medical Device Quality Management System as per ISO 13485, MDSAP and 21 CFR 820 for Small, Medium & Large Businesses organizations

EUROPECERT specializes in helping any organization become ISO 13485 compliant inorder to achieve medical device CE Marking or ISO 13485 Certification.

ISO 13485:2016 is an internationally recognized standard for Quality Management for the Medical Device Industry designed to help manufacturers comply with regulatory systems and understand what they need to do to place compliant devices on markets throughout the world.

We have a very good track record of working exclusively with medical device companies planning for CE Marking across the globe. Our services are structured such a way idel for large , medium and small companies.

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