Post-Market Surveillance Requirements for Medical Devices
€229.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Articles 83–89 · Annex III · US & Australia
Post-Market Surveillance Requirements for Medical Devices
The surveillance loop end to end — from the plan that starts it to the file that records what it changed.
€229
VAT calculated at checkout
10 modules · 3h 21 · workbook
· certificate
Access does not expire
Most surveillance systems produce records, not evidence
A plan that could belong to any device on the market. Indicators with thresholds nobody has ever crossed, on any product, in any year. Complaints handled correctly one at a time, and never looked at together.
None of these are hard problems. They are the consequence of building surveillance as a set of procedures rather than as a loop that has to close.
This course follows that loop from the plan that starts it to the file that records what it changed.
- 10 modules
- 3h 21 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 interpretation rather than a rule, the course says so.
01
The regulation
Articles 83 to 89 and Annex III for the system, the plan and the reports. Annex XIV Part B for clinical follow-up. Article 32 for the summary of safety and clinical performance.
02
Beyond Europe
Vigilance reporting in the United States and in Australia, with the criteria, the deadlines and the forms — and what changed in the American inspection framework in February 2026.
03
The standards
ISO 13485 for the quality system, ISO 14971 and ISO 24971 for post-production risk management, and ISO/TR 20416 for surveillance.
Outline
10 modules, in the order the process runs
Outcomes
What you will be able to do
01
Write a plan that survives review
Annex III as a checklist, with an action and an owner attached to every threshold.
02
Decide reportability confidently
Against the right deadline, knowing which clock started when.
03
Assemble a PSUR that supports itself
Including the denominator that turns an incident count into a rate.
04
See your file the way a reviewer will
And predict fairly accurately what they will find in it.
Audience
Who the course is for
- Quality and regulatory professionals who own this process
- The person responsible for regulatory compliance
- Anyone preparing a technical file or a certification audit
- Consultants running surveillance for several manufacturers
It assumes familiarity with medical device regulation and with a quality management system. It does not assume prior study of the articles and annexes it covers.
What is included
What you get when you buy
- 10 video modules, 3h 21 in total
- A downloadable transcript for every module
- A test at the end of each module, and a final test
- The gap analysis workbook, as a PDF
- 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
Does it cover the IVDR as well as the MDR?
Yes. The in vitro diagnostic regulation is addressed alongside the medical device regulation wherever the requirements differ, article by article.
Does it cover markets outside Europe?
It covers vigilance reporting in the United States and in Australia, with the reportability criteria, the deadlines and the submission routes for each — and what changed in the American inspection framework in 2026.
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 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.
Course and kit
The course explains the reasoning. The kit gives you the structure.
The workbook is a gap analysis of your own documentation, arranged in the order an assessment runs. Working through it produces a list of what is missing or partial in your file — and that list maps to the templates in the Post-Market Surveillance Kit.
Post-Market Surveillance
10 modules, 3h 21 of video, downloadable transcripts,
workbook and certificate. Self-paced, with no expiry.
€229.00
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