ISO 13485 is a quality management system standard for manufacturers of medical devices. It's very similar to ISO 9001, but imposes stricter controls and documentation requirements. Both ISO 9001 and ISO 13845 contain the same clauses with mostly the same requirements, but there are several notable differences:
If your product includes medical devices or components used by medical device manufacturers, ISO 13485 certification will place you in an elite class of suppliers. Contact us if you're interested in becoming ISO 13485 certified.