Medical Device Software V&V — Course
€229.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
IEC 62304 · IEC 82304-1 · EU MDR
Medical Device Software Verification and Validation
What the software lifecycle standards actually require, how the documentation fits together, and what a notified body opens first.
€229
VAT calculated at checkout
4 modules · 2h 30 · workbook
· certificate
Access does not expire
Most software files fail review for the same handful of reasons
A safety class stated without a rationale. A SOUP register that names components but never says what they are relied on to do. Test records that hold every result and never say which version was tested.
None of these are hard problems. They are the consequence of learning IEC 62304 as a list of requirements rather than as a sequence of documents you have to be able to produce.
This course goes through that sequence in the order you would actually apply it.
- 4 modules
- 2h 30 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
The general safety and performance requirements that apply to software, the design and development obligations, and how software sits in the technical documentation.
02
The standards
IEC 62304 for the software lifecycle — planning, architecture, units, integration, system testing, SOUP and maintenance. IEC 82304-1 for health software as a product.
03
The connections
How the lifecycle file, the risk management file and the clinical evaluation refer to each other, and what happens when one of them moves.
Outline
4 modules, in the order the process runs
Outcomes
What you will be able to do
01
Classify software the way the standard means it
Per item, revisited on change, with the reasoning recorded.
02
Build a lifecycle file that traces
Requirements to architecture to units to tests, in both directions.
03
Handle SOUP without hand-waving
Selection, evaluation, versions, and what the failure of each one does.
04
Read your own file the way a reviewer will
And predict what they will ask before they ask it.
Audience
Who the course is for
- Software and quality engineers on medical device teams
- Regulatory affairs professionals reviewing software files
- The person responsible for regulatory compliance
- Consultants preparing technical documentation for 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
- 4 video modules, 2h 30 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
Do I need to be a developer to follow it?
No. The course explains what the standards require of the documentation and how the parts fit together. It assumes you have met a quality management system before, not that you write code.
Does it cover artificial intelligence and machine learning?
Not as a dedicated module. The lifecycle requirements it covers apply to machine learning components as they do to any other software, but the specific evidence expectations for learning systems are addressed in the Clinical Evaluation course.
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 Software Documentation Kit, Software Documentation Kit Gold.
Software V&V
4 modules, 2h 30 of video, downloadable transcripts,
workbook and certificate. Self-paced, with no expiry.
€229.00
Related products
