RAPS' Western Canada Chapter brings in Health Canada's own Medical Devices Directorate to walk through MDSAP updates — remote audits, common findings and oversight of auditing organizations — virtually, .
Dates and format
- Date: 22 October 2026 (exact time not published in sources reviewed)
- Format: virtual chapter event
- Organizer: RAPS, Western Canada Chapter
- Speaker: Fred Hamelin, Health Canada Medical Devices Directorate
What it covers
Fred Hamelin covers popular MDSAP topics for 2026: remote and hybrid audits, common audit pitfalls and findings, oversight of auditing organizations, and how the program treats manufacturers of legacy medical devices (MLMD) and software as a medical device (SaMD), plus upcoming developments in the program, per RAPS' session description.
Who should attend
Quality and regulatory professionals at device manufacturers audited under MDSAP, and anyone tracking Health Canada's audit expectations for legacy devices and SaMD. A regulator briefing straight from the program's own Quality Systems Section is a direct line to what auditors will actually check next cycle.
Working through a broader device compliance program? AAMI's Medical Device Software Validation course runs the week after, and RAPS Workshop: EU Medical Device Regulation 2017/745 covers the EU side of the same compliance picture.
Frequently asked questions
Who is speaking at this RAPS MDSAP webinar?
Fred Hamelin, Manager of the Quality Systems Section of Health Canada's Medical Devices Directorate, covering remote and hybrid audits, common audit findings, oversight of auditing organizations, and MLMD/SaMD developments under MDSAP, per RAPS' event listing.
Is this webinar free?
RAPS' Western Canada Chapter frequently offers virtual chapter events at no cost to members, but this listing could not confirm a fee (or its absence) for this specific session — check RAPS' event page before registering.
What is MDSAP?
The Medical Device Single Audit Program lets a single audit satisfy the regulatory requirements of multiple participating authorities, including Health Canada, the FDA, Australia's TGA, Brazil's ANVISA and Japan's PMDA.
Sources & further reading
- RAPS. Western Canada Chapter Virtual Event: Health Canada's Medical Device Single Audit Program (MDSAP) Updates 2026. raps.org
- RAPS. Upcoming Events — Western Chapter Virtual Event: Latest Health Canada MDSAP Advancements. raps.org
Event details are published by the organizer and can change. This listing was corroborated through web search rather than a direct fetch of the organizer's page (network egress was blocked this session) — confirm date, time and access with RAPS before making plans. Last verified 27 September 2026.
