This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

MedTech Summit
Hybrid Event, 20 - 24 June 2022
In-Person: Clayton Hotel Burlington Road, Dublin, IrelandDigital Experience: One track will be live-streamed each day in BST time zone, with on-demand recording access for all other tracks made available from the afternoon of the following day. Learn more on the Digital Experience page.

Alberto Colombo
MD Compliance Expert and Associate Partner at PQE Group

Profile

Over 16 years of experience in pharmaceutical and medical device environments with extensive experience in Quality System Compliance. Possesses 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. Proven track record in leading high-performing teams. 

Wide experience in support to Auditing systems for Vitro Diagnostic and Medical Devices quality systems. 

Certified auditor for CE Marking of Medical Devices under Directives 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. Certified auditor for ISO 13485:2016, ISO9001:2015 standards and MDSAP. 

Agenda Sessions

  • IVDR Transitional Provisions: Regulatory Strategy to Address Extended Scope and Timelines

    10:10