Auditing

The Medical Consulting team offers a wide range of audit services: from internal system audits for manufacturers and distributors of medical devices and IVDs 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