To be allowed to manufacture and commercialize medical devices, a manufacturer needs to implement a Quality Management System according to the ISO13485:2016 standard. It is fairly easy to get lost in the documentation.
Do you need some guidance in preparing for the certification? After using our checklist, you'll be ready to get your ISO13485:2016 certificate!
Check out how we implemented the new ISO13485 for Medical Devices
at our client Hubert De Backer.