Mike Wallenstein

Portrait of Mike Wallenstein

Global Head Novartis MDR Implementation & DD&C Compliance, Novartis Pharma AG


Session Title

Journey and lessons learnt by the first company to achieve a certification of their QMS system and product agains the EU MDR

  • Strategy used to adapt a quality system to the MDR
  • Gap assessing your quality system and implementing a plan to adapt and upgrade to continuously improve and meet the MDR and other Global HA requirements
  • What does ready look like? Key lessons learned on the transition.
  • Discuss the product strategy employed and the challenges faced in adapting a legacy platform product to the MDR, which also required an up classification.
  • Outcomes, challenges and strategies for transition and implementation


Mike Wallenstein holds the position as Global Head Novartis MDR Implementation & 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 is a member of several US and EU Expert Committees and Interest Groups on Combination Products, and 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. 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.