MD Compliance Expert @PQE Group - Over 16 years of experience in pharmaceutical and medical device environments with extensive experience in Quality System Compliance. Wide knowledge of MDD (93/42/EEC) & AIMDD (90/385/EEC), IVDD (98/79/EEC) and new Medical Device Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Device Regulation (EU) 2017/746, ISO 13485 and ISO 9001. Qualified Lead Auditor for Notified Body employed in both In Vitro Diagnostics and Medical Devices fields
