US FDA 21 CFR Title 820 (QSR)

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

    • Establish that the quality system is consistent with the complexity of the device, manufacturing processes and size, and the complexity of the manufacturing facility
    • Plan to define and implement effective procedures
    • Implement what has been documented and is going to be done
    • Check the system and make necessary changes (CAPA)
    • Act upon changes and ensure they are implemented

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



Efficient introduction – Regulatory Essentials in Health Tech – training series >>

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