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.
Most documents listed below were published by Health Canada and are in PDF format. Links for Medical Device Regulations
read moreCanada is a well-established but lucrative market for medical devices. It has one-fifth the population of Brazil, but spends nearly as much on heal
read more