Head of Notified Body (non-active medical devices) DQS Medizinprodukte GmbH
Description: Both the MDR and IVDR request that manufacturers explain in their QMS how they manage their devices’ regulatory compliance through a Strategy for Regulatory Compliance.
The regulatory framework is very rich and is constantly evolving: multiple changes to existing regulations since 2017, additional implementing regulations, more than 1000 pages of MDCG guides, very few European Harmonized standards, various regulatory authorities positions, inextricable headache to plan notified bodies product assessments/QMS audits… And do also not to forget the other regulations (Machinery, REACH, PPE, GDPR, AI…). This is the “VUCA” world (Volatility – Uncertainty – Complexity - Ambiguity) of our MD/IVD community.
Hence, defining and maintaining a strategy for regulatory compliance is now considered to be a major challenge for Regulatory professionals. In order to help regulatory professionals overcome this challenge, we hereby present this workshop! As an introduction, attendees will discover or confirm their level of tolerance of uncertainty and to ambiguity using psychometrics.
Furthermore, the workshop will address how strategic management tools can be adapted (or used?) to develop your strategy for regulatory compliance, through the following milestones: • Fundamentals of business strategic management • Strategic position • Strategic choices • Strategy in action • A NB’s perspective
Define a successful medical device strategy for regulatory compliance using strategic management tools
Manage a strategy for regulatory compliance taking into account the environment dynamics
Understand the NB expectation for regulatory compliance according to MDR and IVDR