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

How can we help?

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