The Role of ISO 14971 in Global Medical Device Regulations
Imagine introducing a life-saving medical equipment to the market, only to have it rejected by authorities around the world because it lacked the necessary risk management documentation. In the medical device business, this unfavourable situation occurs more often than you might think. With the global medical devices market worth $542.21 billion in 2024 and expected to grow to $886.68 billion by 2032, the stakes are never higher for producers to get their risk management approach right from the start. Enter ISO 14971—the global standard that has established itself as the pillar of medical device risk management worldwide. This is not just another tick-box compliance exercise; it's your guide to safer devices, more efficient regulatory clearance, and better patient outcomes in the end. Understanding ISO 14971 - The Foundation of Medical Device Safety ISO 14971 provides a structured approach to identifying, analyzing, evaluating, and controlling risks associated with medical device...