Team Lead, Quality and Regulatory Affairs
Labquality has great expertise with quality systems,
including the USA Food and Drug Administration Quality System Regulation, QSR, 21 CFR Title 820.
The QSR requirements are similar to ISO 13485 requirements. However, there are certain differences.
The FDA QSR is a US law that needs to be followed, whereas ISO 13485 status is not similar in the EU.
Quality System Regulation 21 CFR 820
According to the regulation, manufacturers shall
✔ 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 customised and open training for medical device QMS