MD Regulatory Academy
One subject at a time, all the way down
Each course takes a single area of the European medical device regulation and works through it completely: the requirements, the evidence, the documents that result, and the cases most training leaves out.
Approach
Depth, and no survey courses
A course covers one area end to end rather than touring the whole regulation. Where something is an interpretation rather than a rule, it says so — in these subjects there are more open questions than most training acknowledges.
01
The awkward cases are in, not out
Most training covers the straightforward path and stops. These courses spend their time where the work actually gets stuck: legacy products, software, the exceptions that apply to few devices and cost months when they apply to yours.
If a requirement has no settled answer, that is said plainly rather than smoothed over.
02
Maintained as the framework moves
Regulation, guidance and inspection practice keep changing, and modules are revised when they do. The American inspection framework changed in February 2026 and the surveillance course covers it as it stands today.
Updates to a course you already own are included, at no further cost.
Catalogue
Available now
The catalogue grows one subject at a time. Each course covers what the requirement says, how the evidence is built, and what the resulting document has to contain.
Software and artificial intelligence
IEC62304
Medical Device Software Verification and Validation
What the lifecycle standards require of the documentation, how the parts have to trace to each other, and where SOUP is handled properly.
MDR
Artificial Intelligence in Medical Devices — Regulatory Requirements
Qualification and classification of AI-driven devices, the evidence expected of a learning system, and how the AI Act sits alongside the MDR.
18286
EN 18286 in Practice: The Quality Management System Required by the EU AI Act
The quality management system Article 17 requires of a provider of a high-risk AI system, clause by clause, and what it adds to an ISO 13485 system already in place.
Safety and design evidence
ISO14971
Medical Device Risk Management: ISO 14971, ISO/TR 24971 and Artificial Intelligence
Each requirement stated precisely, and shown in the document that holds it — from the acceptability policy to the post-market loop, extended to devices that learn.
62366-1
IEC 62366-1: Usability Engineering of Medical Devices
The usability engineering process one clause at a time, from the use specification to the summative evaluation, with the documents each step has to produce.
10993
Biological Evaluation of Medical Devices
The evaluation plan, chemical characterisation, toxicological risk assessment, and when testing is genuinely required.
22442
Devices Using Materials of Animal Origin
Sourcing, collection, handling and viral inactivation — and the documentation a notified body expects for tissue-derived materials.
Identification and registration
27–29
UDI Management
Building and maintaining the identifiers, what changes trigger a new UDI-DI, and the database modules that are live today.
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Format
Designed to be worked through, not watched
Self-paced and fully online, with progress saved to your account and every module replayable. Transcripts are downloadable, so the content stays searchable long after the video is finished. The certificate carries a verification code a third party can check.
Questions
Common questions
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.
Is the workbook included?
Yes. It is a gap analysis of your own documentation, arranged in the order an assessment runs, and it is 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.