This page tracks the AI Use Qualification Toolkit: which version is current, what changed in each release, and the status of every regulation, guidance document and standard the toolkit relies on.
It is public on purpose. The toolkit includes updates through January 2028, and a promise like that is worth exactly as much as the evidence behind it. This is the evidence — before you buy, not after.
Current version
| Version | 1.1.0 |
| Released | 31 July 2026 |
| Contents | Nine files — governing procedure, interactive triage tool, qualification record, validation plan and report, AI use register, regulatory crosswalk, employee guide, deployment guide, version history |
| Updates included through | 31 January 2028 |
| Sources last verified | 5 August 2026 |
Regulatory watch
The state of every source the toolkit is built on. If your question is has anything I depend on moved?, this is the table.
| Source | Version / date | Status | Notes |
|---|---|---|---|
| FDA, Computer Software Assurance for Production and Quality Management System Software | Final, 3 February 2026 | Current | Supersedes the September 2025 version and was retitled to include “Quality Management System”. Expressly names AI/ML tools as in scope of the framework. |
| 21 CFR Part 820 (QMSR) | Effective 2 February 2026 | Current | Incorporates ISO 13485:2016 by reference at § 820.7. |
| ISO 13485 | 2016 | Current | Clause 4.1.6 — validation of computer software used in the QMS — is the anchor requirement. |
| ISO/IEC 42001 | 2023 | Current | Annex A controls A.2–A.10 are mapped in the crosswalk. |
| ISO/IEC 22989 | 2022 | Current | Terminology and autonomy concepts behind the oversight questions. |
| ISO/IEC 23894 | 2023 | Current | AI risk management guidance. |
| ISO 14971 / ISO TR 24971 | 2019 / 2020 | Current | Applies where an AI failure mode has a foreseeable path to patient harm. |
| 21 CFR Part 11 | In force | Current | Applies where AI output is retained as a required electronic record. |
| EU AI Act (Reg. (EU) 2024/1689) | Amended 2026 | Changing | High-risk obligations were postponed by the 2026 omnibus agreement. The toolkit deliberately says “confirm current dates” rather than asserting them. |
| Health Canada — Medical Devices Regulations (SOR/98-282) | Current to 26 May 2026 | Watching | Sections 32(2)(f), 32(3)(j) and 32(4)(p) require a quality management system certificate to CAN/CSA-ISO 13485 — so clause 4.1.6 binds Canadian licence holders through the same standard. A Health Canada row is planned for the crosswalk. |
Read this the way the toolkit asks you to read its own citations. A status of “Current” means current on the date above and nothing more. Guidance gets reissued, standards get revised, and legislative timetables slip. Where a decision of yours turns on one of these, verify it yourself at the moment you rely on it. That is the standard the toolkit sets for AI outputs, and the product holds itself to it.
Release history
1.1.0 — 31 July 2026
First public release.
Nine files covering the qualification of AI tools used inside a medical device quality management system: a governing procedure with four risk tiers, an offline triage tool that assigns them, the records to capture the decision, a register to maintain it, and a clause-by-clause crosswalk to the requirements behind it.
How updates work
- Included through 31 January 2028. Any update published before that date is yours at no extra cost.
- You are emailed when a significant update ships, and the current version is always available to re-download from your order history.
- Every update ships with release notes. The VERSION HISTORY document lists what changed, in which document, and whether a document you have already issued under your own document control is likely to need a change. Each change carries an impact marker — no action, review, or action likely.
- Updates are made at our discretion. No particular schedule is promised, and no commitment is made to cover any specific regulatory change.
Found something wrong?
If a clause reference is incorrect, a citation has gone stale, or something in the toolkit does not survive contact with a real inspection — please tell us at help@redhenadmin.com.
Nothing on this page is legal or regulatory advice, and nothing here establishes the position of the FDA, any notified body, any certification body or any other regulator.