Building Evidence, Ensuring Compliance: Navigating the Medical Device Lifecycle

The development of medical devices is becoming increasingly challenging due to rising regulatory requirements and the growing need for robust clinical evidence. This presentation highlights the interplay between product development, clinical evaluation, and regulatory compliance. Participants will gain practical insights into how safety, performance, and compliance can be ensured throughout the entire medical device lifecycle.

Speaker:
Judith Oriwal, Head Legal Manufacturing Services at Effectum Medical
Expertise: Risk management, engineering, technical documentation, Supply Chain Setup and Management, Re-Processing and Sterilization, production