OPINION Post-market activities have long been overlooked in the medical device industry, yet recent discussions highlight their vital importance in ensuring patient safety and product efficacy. The white paper from…
OPINION The IMDRF Strategic Plan 2021-2025 highlights the evolving landscape of medical device regulation, which is crucial for fostering innovation while ensuring patient safety. As technology advances at a breakneck…
OPINION The integration of artificial intelligence and machine learning into medical devices presents a transformative opportunity for the healthcare sector. However, with this innovation comes the undeniable need for rigorous…
OPINION The decision to move all IMDRF membership forms online by May 2025 is a significant step in the evolution of regulatory processes within the medical device industry. Digital transformation…
OPINION The upcoming bilateral meeting between the European Medicines Agency (EMA) and the Association of the European Self-Care Industry (AESGP) represents a pivotal moment for the future of self-care products…
OPINION The landscape of healthcare is evolving rapidly, and with it, the necessity for robust Quality Management Systems (QMS) cannot be overstated. As organizations strive to align their practices with…
OPINION In an era where information overload is the norm, the introduction of RSS feeds for IMDRF activities presents a refreshing approach to engaging stakeholders. This technology, although not new,…
OPINION The recent updates from the IMDRF Working Group are a crucial step in the ongoing evolution of medical device regulation. As the healthcare landscape continues to change rapidly, it’s…
OPINION The landscape of in vitro diagnostic (IVD) medical devices has become increasingly competitive, making clinical evidence a pivotal element in their marketing strategies. While companies may be tempted to…
OPINION The workshop on the Essential Principles of Safety and Performance of Medical Devices is a timely reminder of the paramount importance of these principles in the healthcare sector. In…