Free templates
Each one comes with worked examples, drop-downs and practitioner notes, and cites the standard or FDA guidance it's built on without reproducing it. Enter your name and work email and the download starts here.
Excel workbook
A register for identifying, evaluating and monitoring every piece of software of unknown provenance, with the columns auditors check first: exact version and known-anomaly review.
IEC 62304:2006/AMD1:2015 · AAMI/IEC TIR80002-1:2009
Excel workbook
An SBOM you can fill in today, plus a 21-item checklist of what FDA expects in a premarket submission for a cyber device, including the software Documentation Level.
FDA cybersecurity guidance (Feb 3, 2026) · Section 524B
Excel workbook
A software FMEA with sample severity and probability scales, a failure mode library, a cause library and worked examples, with residual risk calculated for you.
ISO 14971 · IEC 62304 · ANSI/AAMI SW91:2018
Excel workbook
A step-by-step template for what a change touches, what it does to risk, what must be re-verified, and whether it needs a new submission.
IEC 62304 · TIR80002-1 · FDA software change guidance (2017)
Not sure which you need? Start with the IEC 62304 safety class calculator or the Documentation Level evaluator; each result points to the right template.
General guidance written by Frank Clay, CSQE. The templates don't reproduce or replace any standard or FDA guidance, and they aren't legal or regulatory advice. I'll add you to my contacts; I won't sell or share your details.