In August of 2018 the Food and Drug Administration announced that it will be using ISO 13485:2016, the latest evolution of the International Standard Organizations 13485 standards for medical devices, as the basis for its quality system legislation. This standard, which is used throughout the world, is now the basis for medical device regulatory law in the United States.
Some general requirements of the specification from Section 4.1 are:
1) The organization shall document a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard and applicable regulatory requirements.
2) The organization shall establish, implement and maintain any requirement, procedure, activity or arrangement required to be documented by this International Standard or applicable regulatory requirements.
3) The organization shall determine the processes needed for the quality management system and the application of these processes throughout the organization taking into account the roles undertaken by the organization.
ISO 13485:2016 specifies controls for virtually everything involved in the lifecycle of a medical device: from design through development and production to final use and servicing. The standard applies to companies regardless of their size or place in the device supply chain. The standard also applies to work on a medical device done by outside vendors or service providers. If your company is certified, then your company is responsible for making sure that all applicable work or parts that go into a medical device product meets the standard. Hence, it is smart, good business to simply deal with other ISO 13485:2016 certified companies.