- setup / documentation, implementation, support / administration of quality management
systems for manufacturers and suppliers of medical devices according to:
- EN ISO 9001:2015
- EN ISO 13485:2016
- GxP (e. g. cGMP)
- consolidated / integriated QM systems (e. g. EN ISO
9001/13485)
- setup / documentation, implementation, support / administration of risk management
systems for manufacturers and suppliers of medical devices according to:
- medical device surveillance (PMS)
- validation of tools and processes
- compliance management
Druckversion 