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Medical Devices

Collaboration Works: Risk Management – Clinical Evaluation – PMS/PMCF United

Wednesday, May 8, 2024
10:25 – 11:25 CEST
Location: B 05 + B 06
Learning Level: Expert

Description: In the realm of medical device regulatory affairs, the seamless convergence of risk management, clinical evaluation, and post-market surveillance is key. Without it, we'll continue with inconsistencies, lack of solid evidence and frustrated colleagues. The known consequences: many questions from conformity assessment bodies and delay in market approval. This session encapsulates the importance of the synergy, uniting experts and stakeholders to discuss the current obstacles and shine a light on the industry's future needs.

We'll focus on the exploration of the unified interface between risk management, clinical evaluation, and post-market surveillance. Discover how this synergy enhances safety, efficacy, and compliance, benefiting patients and advancing the industry.

Learning Objectives:

  • Upon completion of this session, participants should be able to describe the main obstacles we are currently facing regarding the interfaces of Risk-Clinical-PMS.
  • Upon completion of this session, participants should be able to explain the need to promote better business practices that will improve the industries situation.