Production & Quality System Software

Not every piece of software inside a quality system is the medical device itself — the production line software, the spreadsheets, the cloud tools still need validating under 21 CFR 820 and ISO 13485. AAMI's two-day virtual course on 12–13 November 2026 is built around exactly that distinction.

Dates and format

• Date: 12–13 November 2026, two 8-hour days, 9:00am–6:00pm EST
• Format: online, live instructor-led via Zoom
• Organizer: Association for the Advancement of Medical Instrumentation (AAMI)
• Registration: open enrollment through AAMI's own training catalog

What it covers

The course's scope is production and quality system software — the tools that run manufacturing and the quality system itself, not software embedded in or constituting the medical device. It works through the basic elements and strategies for efficiently validating that software under 21 CFR 820, ISO 13485 and MDSAP, and how to pick the right validation approach from ISO/TIR 80002-2 and FDA guidance depending on whether the software is custom-built, off-the-shelf, a spreadsheet, or cloud-based.

Who should attend

Quality engineers and auditors who sign off on computer system validation, plus manufacturing and process engineers who select or configure production software, and the regulatory compliance staff who answer for it at inspection. It is a distinct topic from validating software that is itself the medical device or part of it — for that side, see AAMI's Medical Device Software Validation course, running a few weeks earlier. For the 510(k)/De Novo submission side of the same quality system, AAMI's Navigating 510(k) & De Novo Requirements course covers premarket pathways.