Auditing

Auditing

The Medical Consulting team offers a wide range of audit services: from internal system audits for manufacturers of Medical Devices, IVDs and Cosmetics to supplier qualification and control audits.

The most widely provided services include audits, pre-audits and gap analyzes for verifying the requirements of the Quality Management System according to the standards:

  • MDD directive
  • Regulation (EU) 2017/745 MDR
  • Regulation (EU) 2017/746 IVDR
  • MDSAP program
  • 21 CFR 820
  • ISO 13485:2016
  • ISO 9001:2015