AI, MDR, and Beyond: Lessons from RAPS Lisbon
Following the recent RAPS Euro Convergence in Lisbon, we sat down with one of our college Dr. Leigh-Anne Dell-Brown to reflect on the key discussions, emerging trends, and practical insights shaping the medical device industry. From the evolving role of artificial intelligence in regulatory processes to the growing emphasis on transparency and patient-centered communication, the […]
From Silos to Synergy: Connecting Clinical Evaluation, Risk Management, and PMS/PMCF Under the MDR
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 continuous feedback loop. […]
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 […]