Clinical Investigation of Medical Devices for Quality in Pharma

This training program on clinical investigation of medical devices is designed for Quality professionals in the Pharma sector. It addresses the challenge of ensuring compliant clinical investigations that meet regulatory expectations for safety, performance, and data integrity. Participants will gain the ability to establish quality oversight, evaluate investigation documentation, and maintain compliance with ISO 14155 requirements. The program uses clinical investigation scenarios, compliance reviews, and documentation evaluation exercises to ensure practical application.