EU Regulatory Readiness for Health AI Vendors
7 modules · 0 completed
Modules
- 1. Map Your ProductAvailable
- 2. Is It a Medical Device?Available
- 3. Understand Your Likely ClassificationAvailable
- 4. Plan Your Conformity StrategyAvailable
- 5. Build Your Clinical Evidence PlanAvailable
- 6. Add the EU AI Act LayerAvailable
- 7. Build Your QMS & Lifecycle PlanAvailable
About this course
A complete vendor track for health AI teams. Seven modules take you from a stable product picture, through qualification and classification reasoning, to a conformity strategy, a clinical evidence plan, the EU AI Act overlay and a QMS and lifecycle plan — assembled into a Regulatory Readiness Blueprint v1.0 you can hand to your advisers. It structures regulatory reasoning; it never concludes device status, framework applicability, class, route or readiness.
Practitioner · 7 released modules
- Who it is for
- Founders, product leads and early regulatory owners at health AI vendors.
- What you will be able to do
- Document a reviewable regulatory starting point end to end: product boundary, intended purpose, qualification assessment, preliminary classification position, conformity strategy, evidence plan, AI Act overlay and lifecycle plan.
- What it assumes
- Working knowledge of your own product and its supported configurations.
- Key topics
- Choosing the regulatory unit · Supported configurations, not the demo · Workflow and data-flow mapping · Generated vs pass-through output · Patient-specific routes and device links · Use context and human role
Also useful with this course
- Practice · Regulatory Classification Lab
How this content was reviewed
AI-assisted authoring was followed by structural checks, cross-model AI review and synthetic-user testing. No human clinical, regulatory, scientific or legal expert validation is currently claimed.
- AI-assisted authoring — completed
- Deterministic structural QA — completed
- Cross-model AI review — completed
- Synthetic-user testing — completed
- Human domain-expert review — not yet completed
Status checked 19 September 2026. Primary regulatory and legal summaries checked 25 August–10 September 2026.
From product facts to a defensible regulatory starting point
EU Regulatory Readiness for Health AI Vendors
A complete vendor track for health AI teams. Seven modules take you from a stable product picture, through qualification and classification reasoning, to a conformity strategy, a clinical evidence plan, the EU AI Act overlay and a QMS and lifecycle plan — assembled into a Regulatory Readiness Blueprint v1.0 you can hand to your advisers. It structures regulatory reasoning; it never concludes device status, framework applicability, class, route or readiness.
Map Your Product
Before asking what class you are, build a stable picture of the thing you are regulating: the regulatory unit and its dependencies, the input → processing → output → user → action chain, generated versus pass-through information, patient-specific routes, supported configurations, use context, and the claims your company actually controls.
Is It a Medical Device?
Turn the fact base into a disciplined qualification assessment: intended purpose as the regulatory anchor, the EU Medical Device Regulation (MDR) Article 2(1) medical-purpose families, the Medical Device Coordination Group (MDCG) software qualification sequence, device and accessory linkage, the specimen-gated MDR/In Vitro Diagnostic Medical Devices Regulation (IVDR) boundary, and a red-team pass over the story before you rely on it.
Understand Your Likely Classification
How MDR classification is reasoned and documented: intended purpose governs classification, independent software is classified in its own right, the strictest applicable rule wins, Rule 11(a) decision impact, Rule 11(b) monitoring, the narrowness of 11(c), competing rules and linked devices — ending in a learner-authored preliminary classification position, never an automated class.
Plan Your Conformity Strategy
How conformity assessment is structured and what it demands of a small software manufacturer: Article 52 route logic by class, technical documentation as a traceable chain, what a notified body does and does not do, and which workstreams your working position sets in motion — ending in a learner-authored Conformity Strategy Worksheet with an explicitly preliminary route hypothesis.
Build Your Clinical Evidence Plan
Claim → evidence → gap → action, claim by claim: valid clinical association, technical and analytical performance, clinical performance, what literature and internal validation can and cannot carry, prospective and live evidence, and how to name a gap precisely enough to fund it — ending in a learner-authored Clinical Evidence Plan.
Add the EU AI Act Layer
Three questions kept apart — the MDR/IVDR question, the AI Act question, and what can serve both: provider, deployer and value-chain roles, the Article 6 routes into the high-risk regime, the transparency and general-purpose layers that apply independently, and the reuse/extend/new map — ending in a learner-authored AI Act Overlay with an explicitly preliminary high-risk hypothesis.
Build Your QMS & Lifecycle Plan
The operating system behind everything you have written, learned through a change-impact exercise: quality-management processes and owners, design and change control for software that ships continuously, supplier and foundation-model dependencies, post-market surveillance, PMCF, vigilance and CAPA — ending in a learner-authored QMS & Lifecycle Plan and the assembled Regulatory Readiness Blueprint v1.0.
Your Regulatory Readiness Blueprint collects everything you write in this track.
Open the BlueprintAbout this course
Practitioner · 7 released modules
- Who it is for
- Founders, product leads and early regulatory owners at health AI vendors.
- What you will be able to do
- Document a reviewable regulatory starting point end to end: product boundary, intended purpose, qualification assessment, preliminary classification position, conformity strategy, evidence plan, AI Act overlay and lifecycle plan.
- What it assumes
- Working knowledge of your own product and its supported configurations.
- Key topics
- Choosing the regulatory unit · Supported configurations, not the demo · Workflow and data-flow mapping · Generated vs pass-through output · Patient-specific routes and device links · Use context and human role
Also useful with this course
- Practice · Regulatory Classification Lab
How this content was reviewed
AI-assisted authoring was followed by structural checks, cross-model AI review and synthetic-user testing. No human clinical, regulatory, scientific or legal expert validation is currently claimed.
- AI-assisted authoring — completed
- Deterministic structural QA — completed
- Cross-model AI review — completed
- Synthetic-user testing — completed
- Human domain-expert review — not yet completed
Status checked 19 September 2026. Primary regulatory and legal summaries checked 25 August–10 September 2026.