SoftwareCPR Instructors!
Our General Manager and Partner, Brian Pate, will be teaching an upcoming (October 27-29, 2026) Association for the Advancement of Medical Instrumentation (AAMI) course on medical device software validation.
What is the AAMI course on medical device software validation?
AAMI’s course on Medical Device Software Validation covers FDA, EU MDR, cybersecurity, cloud computing, and mobile app requirements for medical device software. The training combines the relevant laws, regulations, standards, and guidance with real world exercises in software classification and validation. Professionals in software engineering, software quality, regulatory, or compliance, are invited to register.
What will attendees gain?
Attendees will gain an understanding of current software guidance and standards from the perspective of medical device software. The course fee includes a digital copy of the ANSI/AAMI/IEC 62304 standard, the presentation slides and case studies, pertinent FDA documents, and additional references.
What does the course cover?
At the conclusion of the 3-day virtual course, attendees will be able to:
- Explain the requirements for developing and validating medical device software, including the 21st Century Cures Act, 21 CFR 820, EU MDR and IVDR, ISO 13485, ANSI/AAMI/IEC 62304:2006/A1:2015, ISO 14971, and ANSI/AAMI/IEC 80002 1:2009
- Review applicable guidance, including the General Principles of Software Validation, IMDRF SaMD, Mobile Medical App, Cybersecurity Premarket, Cybersecurity Post Market, AAMI TIR57 Medical Device Security, and Premarket Submissions for Medical Devices with Software
- Explain the relationship between FDA and MDR medical device classes, software safety classes, and software development and validation activities
- Understand the required activities for developing and validating medical device software
- Understand the FDA and EU regulatory submission requirements for the various classes of software
Location
Course is Virtual | 9:00 AM to 6:00 PM EST
Want to learn more about the course? Fill out the form below and we will contact you.
Check out SoftwareCPR posts on software validation, and see what consulting services we offer.
