ISO 13485 Medical Devices — Quality Management Systems
Confirms that safety and performance are assured across the design, production and distribution of medical devices.
ITS own scheme
This standard is not covered by our IAS or UAF accreditation scopes. ITS certifies it under its own scheme. See our accreditations →
Who this is for
- Medical device manufacturers and importers
- Contract suppliers of components, sterilisation and packaging
- Companies preparing to enter overseas medical device markets
What certification gives you
Forms the basis for medical device approval at home and abroad
Makes the product traceable from design through post-market activity
Improves readiness for regulatory inspection