From Silos to Synergy: Connecting Clinical Evaluation, Risk Management, and PMS/PMCF Under the MDR
Table of Contents Under Regulation (EU) 2017/745, aka MDR, medical device manufacturers face stricter requirements for demonstrating safety, performance, and clinical benefit throughout a product’s lifecycle. While many organizations treat Clinical Evaluation, Risk Management, and Post-Market Surveillance/Post-Market Clinical Follow-up (PMS/PMCF) as separate regulatory obligations, the MDR clearly expects these processes to be interconnected, forming a […]
ISO/DIS 18969: Establishing a Global, Methodological Reference for Clinical Evaluation
The clinical evaluation of medical devices constitutes a fundamental element of regulatory conformity assessment across global markets. Regulatory frameworks such as Regulation (EU) 2017/745 for Medical Devices (MDR) establish legally binding requirements for clinical evaluation; however, they do not prescribe a fully harmonized and reproducible methodology for conducting, documenting, and maintaining clinical evaluations throughout the […]