RAPS runs its recurring Software as a Medical Device workshop as a two-day virtual session — and — comparing how SaMD is regulated across jurisdictions, from US digital health guidance to the EU's framework for medical device software.
Date and format
- Dates: 16 and 18 November 2026 (two-day virtual workshop)
- Format: virtual
- Organizer: Regulatory Affairs Professionals Society (RAPS)
- Registration: via RAPS's workshop page; regular pricing $1,020 members / $1,200 non-members through 16 November 2026
What it covers
RAPS's Software as a Medical Device workshop walks through how SaMD is regulated across jurisdictions: US regulatory guidance on digital health and software, a summary of international SaMD regulation, and the EU's regulatory framework and guidance for medical device software (MDSW), including SaMD. A central question the workshop works through is qualification and classification — whether a given software product is a medical device at all — alongside cybersecurity and quality-system and design considerations that follow from that classification.
Who should attend
Regulatory affairs, quality and software or product development professionals working on products that may qualify as Software as a Medical Device, especially where a company needs a working comparison of US, EU and other jurisdictions' SaMD rules rather than a single-market view.
It sits alongside RAPS's other 2026 device-focused sessions, including its AI medical device regulations workshop and its medical device cybersecurity workshop; the full events directory lists every RAPS session we have verified.
Frequently asked questions
When is the RAPS Software as a Medical Device workshop?
16 and 18 November 2026, a two-day virtual workshop. Daily session times were not confirmed in the sources reviewed — check RAPS's own event page.
Who runs the workshop?
The Regulatory Affairs Professionals Society (RAPS), as a recurring sitting of its Software as a Medical Device workshop series.
What does the workshop cover?
RAPS's SaMD workshop series covers US digital health and software guidance, a summary of international SaMD regulation, the EU regulatory framework for medical device software, how to qualify and classify a product as SaMD, cybersecurity, and quality-system and design considerations across the product lifecycle.
Who should attend?
Regulatory affairs, quality and software/product teams working on products that may qualify as Software as a Medical Device, across more than one jurisdiction.
Is there a fee?
Per RAPS's own page, regular pricing from 16 October to 16 November 2026 is $1,020 for RAPS members and $1,200 for non-members; an earlier-bird rate ended 15 October 2026.
Sources & further reading
- RAPS. Workshop: Software as a Medical Device, 11/16-18/2026. raps.org
Event details are published by the organizer and can change. This listing was verified via WebSearch corroboration of RAPS's own page rather than a direct fetch, because this session's network egress could not reach raps.org directly, and only a single primary source could be found (disclosed in provenance) — confirm date, format and registration with RAPS before making plans. Last verified 31 October 2026.
