Get ready for your ISO13485:2016 certification!

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! 

QD200504 iPDF ISO13485 checklist_DEF-1

 

 
 

Implementation of ISO13485:2016

Check out how we implemented the new ISO13485 for Medical Devices
at our client Hubert De Backer.

How to use our Checklist ISO13485:2016

1.) DOWNLOAD OUR CHECKLIST
Download our checklist as the tool you need to get ready for your ISO13485:2016 certification.

2.) IMPLEMENT THE DIFFERENT STEPS
Implement all the different steps of our checklist. Complete every step to know you're 100% ready for the ISO13485:2016 certification.

3.) BOOK A FREE CALL/MEETING WITH OUR MEDICAL DEVICE EXPERT
Any specific questions about this checklist or about medical devices in general, then book a free call with our Medical Device-specialist! 

QD200504 iPDF ISO13485 checklist_DEF-1