Achieving QMS compliance in Canada for medical device and IVD companies
Achieving QMS compliance in Canada for medical device and IVD companies
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).
About the Author
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.