ISO 13485
Labquality provides medical device manufacturers help with setting up quality management systems (QMS).
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According to Regulations 2017/745 (MDR) and 2017/746 (IVDR), manufacturers need to establish, document, implement, maintain, This is most conveniently performed by following ISO 13485, a QMS standard to be harmonized with the regulations. |
Labquality can help manufacturers in every step of the way by:
✔ 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
WE ALSO OFFER TRAINING ON THE SUBJECT:
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