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.