Posts tagged ISO 13485:2016
Understanding ISO 13485:2016

ISO 13485 was revised in 2016 with several new requirements and a stronger emphasis on risk and planning. In fact, the older 2003 version did not define the term “risk” under Terms and Definition (Clause 3). A considerable amount of detail is now provided to clarify the concept of risk, which pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements within the scope of the revised standard.

Read More