ISO 14971, ISO/TR 24971 and Artificial Intelligence
€229.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
ISO 14971 · ISO/TR 24971 · ISO/TS 24971-2 · EU MDR / IVDR · EU AI Act
Medical Device Risk Management: ISO 14971, ISO/TR 24971 and Artificial Intelligence
From the acceptability policy to the post-market loop — each requirement stated precisely, and shown in the document that holds it.
€229
VAT calculated at checkout
13 modules · 3h 25 · workbook
· certificate
Access does not expire
Complete in form, thin in substance
Most risk management files contain a hazard table, a set of scores and a report. They satisfy the structure of the standard, and they cannot answer the question the whole exercise exists for.
A hospital calls to report that the device produced a result that led to a patient being managed incorrectly. Within an hour: is that situation in your file, what did you estimate its probability to be, what control was supposed to prevent it, and was that control ever shown to work?
The gap between the two is not usually a matter of effort. It is a small number of structural decisions, most of them taken in the first week — and this course is about making them deliberately.
- 13 modules
- 3h 25 of video
- Self-paced
- Workbook included
- Certificate on completion
- Access does not expire
Scope
What the course covers
Every requirement is quoted with its clause and the corresponding article of the regulation. Where the two differ, the course says which prevails — and there are three places where the European requirements exceed the standard, each of which invalidates a common practice.
01
The three standards
ISO 14971 states the requirements, ISO/TR 24971 supplies the method, and the technical specification adds a layer for devices that incorporate machine learning. All three share clause numbering 4 to 10, and the course keeps them aligned throughout.
02
The two regulations
Where risk management appears in the MDR and the IVDR — Article 10, Annex I, Annex II and the post-market surveillance articles — and the three requirements that exceed the standard.
03
The documents
The plan, the hazard analysis, the design and use-related failure analyses, the report and the mapping to the general safety and performance requirements, shown section by section.
Method
Requirement, then the document that holds it
Most courses on a standard explain the clauses. This one also shows the implementation: after each requirement that produces an artefact, an extract of the working document appears on screen, with the section identified, and the narration explains what goes in each field and how to check your own against it.
The extracts are shown for what they teach about filling a field, and they work equally for someone using their own templates.
Outline
13 modules, following the clause sequence
Outcomes
What you will be able to do
01
Write a policy that criteria derive from
Four sentences, four sources, and one of them fixed by European law. It is the document most files do not have, and every criterion in the plan depends on it.
02
Build an analysis that finds what matters
The chain kept in four parts, one row per hazardous situation, and techniques chosen for what each is capable of finding rather than for what is familiar.
03
Verify that a control worked
Not only that it exists. The second verification of clause 7.2 is the one most files do not have, and the course states what counts as evidence for each type of control.
04
Handle a device that learns
Where the dominant hazards arise while everything works as specified, why an analysis built on failure modes finds none of them, and what has to be logged before release.
05
Close the post-market loop
Active collection with named sources, the four review questions including the one that catches invalidated assumptions, and thresholds derived from the file itself.
06
Assess a file and know what to fix first
Three passes, one day, and a work list ordered by dependency rather than by severity — because working in severity order produces work that is redone.
Audience
Who the course is for
- Regulatory and quality professionals writing or maintaining a risk management file
- The person responsible for regulatory compliance
- Engineers and product managers whose device now includes a machine learning component
- Anyone who inherited a file and has to establish what is missing
- Consultants and notified body personnel who assess these files
It assumes familiarity with medical device regulation and no prior study of the standard. The machine learning material is additive: a conventional device manufacturer can follow the course and lose nothing.
What is included
What you get when you buy
- 13 video modules, 3h 25 in total
- A downloadable transcript for every module
- The slides of every module as a PDF
- A test at the end of each module, and a final test
- The gap assessment workbook as a PDF — 25 sections and 183 lines, with conditional sections for machine learning, in vitro devices and legacy files
- 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 ISO 14971?
It helps but is not required: the course quotes the clauses it discusses and does not reproduce the standard. Having your own risk management file open matters more, because most modules end with an exercise performed on it.
Does it cover devices without artificial intelligence?
Yes. The machine learning material is additive and sits in the module where the corresponding clause is treated, so a conventional device manufacturer follows the same sequence and loses nothing.
Does it cover in vitro diagnostics?
A module is devoted to them, because the harm reaches the patient through a clinical decision rather than through contact with the device — and that changes the chain, the severity assignment and the phases that have to be analysed.
Is this a course about passing an audit?
No. Every requirement is justified by what it does for the device and for the people who use it. A file written to satisfy a reviewer and a file written to be usable diverge quite quickly, and only one of them helps when a hospital calls.
We already have a risk management file. Is the course useful?
That is the commonest case. The final module is an assessment method for an existing file, and most modules end with an exercise that produces a quantity from your own documents rather than an impression.
Do you show real documents?
Yes. Where a requirement produces an artefact, an extract of the working document appears with the section identified, and the narration explains what goes in each field. It works equally if you use your own templates.
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.
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 file, ordered by dependency: the policy first, because the criteria rest on it, then the plan, the analysis, the controls and the post-production loop. Working through it produces a list of what is missing or partial — and that list maps to the templates in the documentation kit.
Medical Device Risk Management
13 modules, 3h 25 of video, downloadable transcripts,
workbook and certificate. Self-paced, with no expiry.
€229.00
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