What is IEC 62366-1?

IEC 62366-1 is an international standard that specifies a process for medical device manufacturers to analyze, specify, design, verify and validate the usability of a medical device. Its purpose is to ensure that medical devices are safe and effective for their intended users and use environments. It focuses on applying usability engineering to minimize use errors and associated risks. The standard requires manufacturers to identify potential use-related hazards, design the device to mitigate those hazards, and then verify and validate that the design is usable and safe in real-world scenarios or simulated use conditions. It's commonly used to demonstrate compliance with regulatory requirements for medical devices, helping manufacturers obtain market access globally.