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

Early Registration Savings Deadline Expires In:

  • 00
    Days
  • 00
    Hrs
  • 00
    Mins
  • 00
    Secs
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.

Mike Wallenstein
Global Head Novartis MDR Implementation, External Engagement & DD&C Compliance at Novartis Pharma AG

Profile

Mike Wallenstein holds the position as Global Head Novartis MDR Implementation, External Engagement & DD&C Compliance at Novartis Pharma AG since April 2019. In this role, Mike oversees all activities related to the EU MDR implementation for Medical Devices & Combination Products at Novartis globally.

Prior to this position Mike was functioning as Executive Director QA to oversee all compliance activities related to Medical Devices & Combination Products at Novartis globally.

Mike joined Novartis in 2010 as Global Auditor in Group Compliance and Audit. He has over 25 years of experience in QA, R&D, and Manufacturing within the Medical Devices & Pharmaceutical Industry.

Mike is member of several US and EU Expert Committees and Interest Groups on Combination Products and lecturer at the Universities of Bern/CH and Baltimore/US.

Before joining Novartis, he was Head Global Audit Systems at Gambro Renal Care (today Baxter) and European Head Quality Systems & Audits at 3M.

He studied Chemical Engineering and Plastic Technologies, in Münster, Germany.

Agenda Sessions

  • Notified Body Opinion under the EU MDR - Lessons Learned from a Prefilled Syringe

    09:10