This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
ISO 13485
ISO 13485
ISO 13485 is a Quality Management System (QMS) standard designed specifically for medical devices, and is the most commonly chosen path for companies to meet QMS requirements in major international markets (i.e. Europe, Canada, Japan, Australia etc.). This standard covers areas such as design control, manufacturing processes, corrective/preventive actions, vigilance, Post-Marketing Surveillance PMS and more.