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
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Labquality
How can we help?
Labquality can assist you on
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
- Support 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
Contact us for more information
Meeri Säily
Sales Director, Consulting and Clinical Trials
meeri.saily@labquality.com
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