AAMI's recurring course on medical device software validation returns as a three-day virtual session, –, combining FDA, EU MDR and IEC 62304 requirements with hands-on classification exercises.
Dates and format
- Dates: 27–29 October 2026
- Format: virtual, live instruction over three days
- Organizer: AAMI (Association for the Advancement of Medical Instrumentation)
- Registration: early-bird rate $995/person, non-refundable but transferable, per AAMI's listing
What it covers
The course combines FDA, EU MDR, cybersecurity, cloud computing and mobile-app requirements for medical device software with real-world exercises in software classification and validation, per AAMI's course description. Course materials include a digital copy of the ANSI/AAMI/IEC 62304 standard alongside presentation slides, case studies and pertinent FDA references.
Who should attend
Software engineering, software quality, regulatory and compliance professionals who classify or validate medical device software under FDA and EU MDR frameworks. Related sessions run periodically through the year — AAMI has also scheduled February and June 2026 offerings of the same course.
Working through a broader SaMD strategy? RAPS Workshop: EU Medical Device Regulation 2017/745 runs in November, and Health Canada's MDSAP Updates 2026 covers the audit side the week before.
Frequently asked questions
What does AAMI's Medical Device Software Validation course cover?
FDA, EU MDR, cybersecurity, cloud computing and mobile-app requirements for medical device software, combining the relevant laws, regulations, standards and guidance with hands-on exercises in software classification and validation, per AAMI's course description.
Is the October 2026 course virtual?
Yes — this session runs virtually, 27–29 October 2026, according to AAMI's event listing and a third-party course announcement describing the same dates and format.
How much does the course cost?
AAMI's own listing states a limited early-bird rate of $995 per person (non-refundable but transferable); this listing could not confirm the standard rate after the early-bird period closes.
Sources & further reading
- AAMI. Medical Device Software Validation (October 2026). aami.org
- SoftwareCPR. Virtual AAMI course: Medical Device Software Validation. softwarecpr.com
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 dates, format, price and access with AAMI before making plans. Last verified 27 September 2026.
