US FDA 21 CFR Title 820 (QSR)

How can we help?

✔ Planning the QMS together with the manufacturer according to the QSR regulation   

✔ Helping the manufacturer identify all processes needed for their QSR

✔ Preparing the Quality Manual, QMS process descriptions, templates, databases, and other documentation needed together with the manufacturer

✔ Helping the manufacturer choose and implement electronic QMS when needed   

✔ Helping the manufacturer maintain and continually improve their QMS

✔ Helping the manufacturer with daily QMS activities including nonconformances, feedback, complaints, internal and supplier audits, vigilance, and many others

✔ Offering customized and open training for medical device QMS