Team Lead, Quality and Regulatory Affairs
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