FDA Quality System Regulation (QSR) 21 CFR 820 Services

If you wish to sell your medical or in-vitro diagnostic device into the US market you will first need to have a Quality Management System (QMS) (which is like the ISO13485 standard) that meets the FDA’s Quality System Regulation (QSR).

We will work with your business to provide you with a bespoke QMS which is fully complaint with the FDA QSR.

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EU Stratton House, Bishopstown Road, Cork, Ireland

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