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Resource Library for Medical Device Professionals

3 total results. Show all resources.

Preparing a Canadian MDL Application

This white paper includes a detailed comparison of Health Canada's Medical Device License application and a US FDA 510(k).

17 pages
Oct 7, 2015

Achieving QMS Compliance for Canada Beyond ISO 13485

An in-depth look at Quality Management System (QMS) regulations as they apply in Canada for obtaining a Medical Device License (MDL).

6 pages
Sep 16, 2016

Transitioning to Medical Device Single Audit Program (MDSAP) Compliance

In this white paper, we discuss the steps you should follow to achieve MDSAP certification.

8 pages
Jan 15, 2018