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Mandatory for Class II, III & IV
MDSAP Canada & ISO 13485 Quality-System Readiness
For manufacturers of Class II, III and IV devices, quality-system certification is a core part of the Canadian licensing framework. Health Canada relies on ISO 13485 certification issued through a recognized Medical Device Single Audit Program (MDSAP) auditing organization.
Our MDSAP Support Goes Beyond Certificate Collection
The MDSAP certificate, the technical dossier and the Health Canada licence should not tell three different stories. The legal manufacturer, device scope, manufacturing controls, design responsibilities and post-market processes must remain aligned.
MDSAP gap assessment against ISO 13485 and Health Canada regulatory requirements (SOR/98-282)
QMS scope and certificate alignment with the legal manufacturer and licensed devices
Design and development controls for applicable device classes
Risk-management integration (ISO 14971:2019)
Supplier and outsourced-process controls
Complaint handling and Mandatory Problem Reporting (MPR) interfaces
Recall and advisory notice processes
CAPA and nonconformity controls
Change control and licence-impact assessment
Post-market surveillance and regulatory reporting interfaces
MDSAP audit preparation and response to audit nonconformities
Coordination of regulatory evidence with the QMS and technical dossier
Prepare Your Quality System for MDSAP Canada Audit
Our quality engineers audit QMS procedures, align MDSAP scopes, and coordinate with recognized auditing organizations.