Quality- and riskmanagement for medical devices

  • 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:
    • EN ISO 14971:2012
  • medical device surveillance (PMS)
  • validation of tools and processes
  • compliance management