Description: The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have significantly reinforced post-market surveillance (PMS) requirements, presenting new challenges for manufacturers and regulatory stakeholders. This will explore challenges and practical strategies for efficient PMS implementation under MDR and IVDR. We will navigate the technical challenges and resource demands in PMS, offering insights on avoiding common pitfalls and streamlining processes. The discussion will also include methods for integrating PMS within Quality Management Systems and addressing Notified Bodies' requirements. Additionally, we'll explore the potential of leveraging modern technologies for PMS activities. Join us to gain actionable insights on balancing regulatory compliance with operational efficiency in post-market surveillance.
