ISO 13485 is the international standard recognized for medical device regulations around the world.
It is intended to promote harmonisation in the medical device industry and set a basis for quality system regulations worldwide. We provide services that help manufacturers understand what they need to do to place compliant devices on markets throughout the world.
ISO 13485 standard published in July 2003. This standard is based on the ISO 9001:2000 process model approach. All requirements of ISO 13485 are specific to organisations providing medical devices, regardless of the type or size of the organisation.