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Resource Library for Medical Device Professionals

3 total results. Show all resources.
Download our white paper on Preparing a Health Canada MDL Application
Canada

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
Download our white paper on Achieving QMS Compliance for Canada Beyond ISO 13485
Canada

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
White paper - MDSAP certification
Canada

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