Quality Management System ISO 13485

Labquality provides medical device manufacturers help with setting up quality management systems (QMS).


According to Regulations 2017/745 (MDR) and 2017/746 (IVDR), manufacturers need to establish, document, implement, maintain, keep up to date and continually improve a QMS.

This is most conveniently performed by following ISO 13485, a QMS standard to be harmonized with the regulations.


Planning the QMS together with the manufacturer according to applicable standards and regulations

Helping the manufacturer to identify all processes needed for their QMS

Preparing the Quality Manual, QMS process descriptions, templates, databases, and other documentation needed together with the manufacturer

Helping the manufacturer to choose and implement electronic QMS when needed

Helping the manufacturer to 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



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