In this white paper, we provide a step-by-step guide for complying with QMS requirements in Canada.
This white paper will discuss the requirements for achieving compliance with the Quality Management System (QMS) regulations as they apply in Canada for obtaining a Medical Device License (MDL) under the Medical Device Single Audit Program (MDSAP).
Ken Pilgrim, P.Eng. is a Director of RA/QA for Emergo and is located in Canada. With more than 20 years of experience in quality management, his expertise includes ISO 13485, CMDR implementation and audits, and medical device registration submissions in Canada, the EU, and US.
The chart shown illustrates the Health Canada approval process for In Vitro Devices (IVDs) and is available for download in PDF format. Ho
read moreBelow you will find basic demographic and healthcare market data on Canada, plus specific information about the medical device and healthcare indus
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