US FDA QSR

Quality System Regulation 21 CFR 820

According to the regulation, it is mandatory for manufacturers to:

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

According to the regulation, it is mandatory for manufacturers to:

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

We can assist you with

Planning the QMS together with the manufacturer according to the QSR regulation
Identifying all processes needed for their QSR
Preparing the Quality Manual, QMS process descriptions, templates, databases, and other documentation needed together with the manufacturer
Choosing and implementing electronic QMS when needed
Maintaining and continually improving your QMS
Daily QMS activities including nonconformances, feedback, complaints, internal and supplier audits, vigilance, and many others
Offering customized and open training for medical device QMS

Setting up quality management systems (QMS) for medical device manufacturers.

We know quality systems, including the USA Food and Drug Administration Quality System Regulation, QSR, 21 CFR Title 820.

Improvement of medical device manufacturer’s quality management system (QMS) and GAP analysis.

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