EN 18286 in Practice: The Quality Management System Required by the EU AI Act
€229.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EN 18286 · EU AI Act Article 17 · ISO 13485
EN 18286 in Practice: The Quality Management System Required by the EU AI Act
All 146 requirements of the standard, clause by clause — each one mapped to the document, record or decision it obliges you to hold.
€229
VAT calculated at checkout
10 modules · 2h 44 · workbook
· certificate
Access does not expire
Four ways an Article 17 file goes wrong
A provider implements a harmonised standard cover to cover, then finds at the assessment that part of Article 17 was never in its scope. A quality system describes what the organisation already does, in the vocabulary of the standard. The compliance strategy of clause 4.4 does not exist, so nothing connects to anything.
And the fourth: everything is documented except the one thing being asked for — how do you know it still works.
None of these are hard problems. They are the consequence of reading EN 18286 as a list of clauses rather than as a set of artefacts you have to be able to produce.
- 10 modules
- 2h 44 of video
- Self-paced
- Workbook included
- Certificate on completion
- Access does not expire
Scope
What the course covers
Every requirement in clauses 4 to 10 — 146 of them, plus 8 recommendations. The course does not reproduce the text of the standard, which is protected by copyright; it gives the interpretation, the artefacts and the sequence, with precise clause references throughout.
01
What the standard buys you
The presumption of conformity and its three conditions, what Annex ZA covers, and the three paragraphs of Article 17 that stay with you and need a written rationale.
02
The compliance strategy
Clause 4.4 has no equivalent in ISO 13485 or ISO 9001, and it is the document most often missing from an Article 17 file. Six mandatory elements, built across the course.
03
The AI system life cycle
Requirements against specifications, verification against validation, data management, continuous learning, the supply chain, and the substantial modification decision.
Outline
10 modules, in the order the standard is built
Audience
Who the course is for
- Regulatory affairs and quality managers at providers of high-risk AI systems
- PRRC and quality managers of medical device manufacturers with an AI component
- Consultants building or auditing an Article 17 quality management system
- Internal auditors who will have to assess one
It assumes you already run a quality management system. It does not teach what a quality management system is, and it does not assume prior study of EN 18286.
What is included
What you get when you buy
- 10 video modules, 2h 44 in total
- A downloadable transcript for every module
- A test at the end of each module, and a final test
- The gap assessment workbook, as a PDF — all 146 requirements, in the order a reviewer reads them
- A certificate with a verifiable code
- Every future revision of the course, at no further cost
The certificate
On passing the final test the certificate carries a code derived from your name and the date of completion. An employer, an auditor or a client can confirm it on a public page, and it can be filed as training evidence under ISO 13485 §6.2.
MDR-XXXX-XXXX · mdregulatory.com/verify
Questions
Before you buy
Do I need a copy of the standard?
The course does not reproduce the text of EN 18286:2026, which is protected by copyright and sold under a single-user licence. You will get considerably more from the course with a copy open next to it, and clause references are given throughout so you can go to the text yourself. Buy it from your national standards body.
Does this replace ISO 13485?
No. If you make a medical device with an AI component, both regimes apply in full. The course is built around that case: it sets out what transfers from an existing ISO 13485 system, what has to be extended, and what you have to build from nothing.
Do I need to be certified to ISO/IEC 42001?
No. Nothing in the AI Act requires it and no notified body can demand it. The two documents have different purposes, and the course explains where they overlap and where they do not.
Is EN 18286 mandatory?
No — it is voluntary, like every harmonised standard. But it is the only route with a presumption of conformity attached. Without it you carry the burden of demonstrating equivalent compliance, requirement by requirement.
How is this different from the AI Medical Devices course?
That course covers the product: qualification, classification, data, model, clinical evidence, markets. This one covers the system that governs it — Article 17, EN 18286, and how they sit on a quality management system you already run. They are complementary.
Is the course live, or can I start whenever I want?
It is self-paced. You start when you buy it and work through it at your own speed, from any device. There are no scheduled sessions and no cohort.
How long do I have access?
Access does not expire. The course is tied to your account, and modules updated after your purchase are available to you at no additional cost.
What does the certificate confirm?
That you completed the course and passed the final test. It carries a verification code derived from your name and the date, which anyone can check on a public page. It can be filed as training evidence under your quality management system.
What happens if I do not pass a test?
You can take it again. The rules for each test are shown on screen before you start it.
Can my company buy several seats?
Yes. Get in touch and we will arrange it, including a single invoice and the details your finance team needs.
Course and kit
The course explains the reasoning. The kit gives you the structure.
The workbook is a gap assessment of your own quality system, arranged in the order a reviewer reads a file. Working through it produces a list of what is missing or partial — and that list maps to the templates in the EU AI Act QMS Kit.
EN 18286 in Practice
10 modules, 2h 44 of video, downloadable transcripts,
workbook and certificate. Self-paced, with no expiry.
€229.00
