Artificial Intelligence in Medical Devices: Regulatory Requirements
€279.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
EU AI Act · EU MDR / IVDR · FDA · International
Artificial Intelligence in Medical Devices: Regulatory Requirements
From qualifying the product and writing an intended purpose that holds, to the evidence a reviewer actually asks for — and everything that has to hold in between.
€279
VAT calculated at checkout
16 modules · 5h 20 · workbook
· certificate
Access does not expire
For a learned model, you cannot show how it works
For a conventional device you demonstrate safety and performance by showing the mechanism. It is physical, it can be inspected, and the evidence follows from it.
Nobody wrote the rules a trained model applies. So the demonstration moves: instead of the mechanism, you show the quality of everything around it — where the data came from, how the truth was established, how performance was measured and on whom, what a human can still catch, and how you would know if it stopped working.
Every requirement in every jurisdiction is a version of that substitution. This course works through it in the order a reviewer reads a file.
- 16 modules
- 5h 20 of video
- Self-paced
- Workbook included
- Certificate on completion
- Access does not expire
Scope
What the course covers
Where a requirement is quoted, it is quoted in full and then explained. Where something is an expectation rather than a rule, or industry practice rather than either, the course says which it is — on the slide and out loud.
01
The regulations
The AI Act as it applies to devices, alongside the MDR and the IVDR: qualification, classification, the single conformity assessment, and the dates that actually bind a manufacturer.
02
The guidance
The joint MDCG and AI Board guidance on the interplay, the FDA guidance on lifecycle management and on predetermined change control plans, and the international terminology and good machine learning practice principles.
03
The standards
ISO 14971 with the technical specification for machine learning, IEC 62304 applied to a trained component, IEC 62366-1, and the European standards being written for the AI Act.
Outline
16 modules, in the order a reviewer reads a file
Outcomes
What you will be able to do
01
Qualify and classify, and write it down
Whether the product is a device and an AI system, the class and the risk tier, and a determination that survives an audit two years later.
02
Write an intended purpose that holds
Eight elements, including the two almost always missing: the level of autonomy, and what the device does when the input falls outside specification.
03
Defend a performance figure
Which metric supports which claim, why predictive values do not travel between populations, and what a pre-specified analysis plan protects you from.
04
Make oversight a control, not a sentence
The four conditions that turn human oversight from a line in the manual into something that works at the moment of use.
05
Plan the updates before you need them
A change control plan that gets accepted, and a clear line around what can never go inside one.
06
Detect a device becoming wrong
Monitoring that finds degradation when nothing has failed, no component is broken and no complaint has arrived.
Audience
Who the course is for
- Regulatory affairs professionals working on software or AI-enabled devices
- Quality managers extending an existing system to cover AI
- The person responsible for regulatory compliance
- Clinical and medical affairs staff building the evidence for an AI claim
- Engineering and data science leads who have to produce the documentation
- Consultants and notified body personnel who assess these files
It assumes familiarity with medical device regulation and with a quality management system. It assumes no background in machine learning: the technology is explained only where a regulatory consequence follows from it.
What is included
What you get when you buy
- 16 video modules, 5h 20 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 — including sections for third-party models, generative systems and adaptive devices
- 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 to understand machine learning?
No. The course explains the technology only where a regulatory consequence follows from it. What it assumes is that you know what a technical file is, what a notified body does, and why an intended purpose matters.
The AI Act keeps moving. Will this course date?
Every date and every document status sits in one module, deliberately. The other fifteen talk about requirements and evidence, which change far more slowly. When something moves, that module is updated and the rest of the course remains valid.
Does it cover markets outside Europe?
Yes. Three modules cover the United States route, the international layer that holds the frameworks together, and the markets that accept an authorisation obtained elsewhere — including why the order in which you approach markets is a strategic decision.
Does it cover generative AI and large language models?
Yes, in a module of its own: why most of the existing framework stops applying cleanly, how to evaluate an output that cannot be enumerated, and what can realistically be brought to a notified body today.
We already have a certified quality system. How much changes?
Less than most people expect. The course maps the new obligations onto procedures you already run, and identifies the few that are genuinely additional — data governance, the bias examination, logging, and harm to fundamental rights.
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.
Do I have to finish it in one sitting?
No. Progress is saved to your account, so you can stop in the middle of a module and resume where you left off.
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.
Is the workbook included?
Yes. It is a gap assessment of your own device, arranged in the order a reviewer reads a file, and designed to be worked through alongside the modules rather than read afterwards.
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 device, 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 documentation kit.
Artificial Intelligence in Medical Devices
16 modules, 5h 20 of video, downloadable transcripts,
workbook and certificate. Self-paced, with no expiry.
€279.00
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