Medical Device Software V&V Training Course + SW Documentation Kit
€629.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
IEC 62304 · IEC 82304-1 · ISO 13485 §7.3 · 21 CFR 820.30
Medical Device Software: Course and Documentation Kit
The software lifecycle explained clause by clause, and the twelve templates that turn the gaps you find into a file you can hand to a reviewer.
€629
VAT calculated at checkout
4 modules · 2h 30 · 12 templates
· certificate
Access does not expire
Four ways a software file goes wrong
A team writes the development plan after the software is written, so the plan describes what happened rather than what was decided. A safety class is assigned once, at the start, on the strength of an argument that Amendment 1 stopped accepting in 2015. A SOUP list exists as a dependency dump, with no evaluation attached to any entry and no anomaly review behind it.
And the fourth: verification and validation are treated as the same activity, so the file proves the software was built correctly and never proves it does what the health software product was supposed to do.
None of these are hard problems. They are the consequence of reading IEC 62304 as a list of clauses rather than as a set of artefacts you have to be able to produce.
- 4 modules
- 2h 30 of video
- 12 templates
- 9 Word · 3 Excel
- Self-paced
- Certificate on completion
- Access does not expire
Scope
What the bundle covers
The course walks through the software file clause by clause. The kit gives you the documents that file is made of. Taken together, the workbook you fill in during the course stops being a list of gaps and becomes a list of documents you already have.
01
Where the requirements live
ISO 13485 §7.3 and 21 CFR 820.30 for design and development, IEC 62304 for the software lifecycle, IEC 82304-1 for the health software product. Which one owns which obligation, and what happens where they overlap.
02
Clause 5, end to end
Planning, SOUP, requirements, architecture, detailed design, units, integration, system testing and release — in the order the standard builds them, with safety classification and the Amendment 1 change that invalidated a common strategy.
03
The documents that result
Nine Word templates and three Excel workbooks covering clauses 5, 8 and 9, plus the cybersecurity set: risk assessment and threat model, management plan, vulnerability disclosure policy.
Outline
The course — 4 modules, 2h 30
Templates
The SW Documentation Kit — 12 templates
Audience
Who the bundle is for
- Regulatory affairs and quality managers responsible for a software file
- Software leads and architects writing IEC 62304 documentation for the first time
- PRRC of manufacturers of software as a medical device or devices with embedded software
- Consultants building or remediating a software lifecycle file
- Internal auditors who will have to assess one
It assumes you already run a quality management system and know what design and development controls are. It does not teach programming, and it does not assume prior study of IEC 62304.
What is included
What you get when you buy
- 4 video modules, 2h 30 in total
- A downloadable transcript for every module, and the slide handouts
- A test at the end of each module, and a final test
- The software file gap analysis workbook
- 12 templates — 9 in Word, 3 in Excel
- A certificate with a verifiable code
- Every future revision of the course and of the templates, 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 the standards?
The course does not reproduce the text of IEC 62304 or IEC 82304-1, which are protected by copyright. Clause references are given throughout, so you can go to the text yourself, and you will get more from the course with a copy open next to it. Buy them from your national standards body.
Is this the course and the kit, or only one of them?
Both. It is the Medical Device Software Verification and Validation course and the SW Documentation Kit, sold together in one purchase. They are also available separately if you only need one.
Are the templates ready to use, or examples?
They are working templates, in Word and Excel, with the structure and the section-by-section guidance built in. You fill in your device, your architecture and your test evidence. Nothing is locked or protected.
Does the kit cover safety class C?
Yes. The templates carry every clause 5 activity, and the course explains which of them apply at class A, B and C, including the Amendment 1 change to how a class is assigned and justified.
Does it cover cybersecurity?
Three of the twelve templates do: a risk assessment with threat model, a cybersecurity management plan and a vulnerability disclosure policy. The course covers where those documents attach to the lifecycle file.
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 the templates are yours to keep and to reuse on any number of projects inside your organisation.
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 kit gives you the structure. The course explains why each part of it is there.
Writing from a template is not faster because it saves typing. It is faster because the structure is the part that is hard to get right, and the course is what tells you why each section exists and what a reviewer will look for inside it. Both are lifetime access, and both are yours to keep.
Medical Device Software: Course and Documentation Kit
4 modules, 2h 30 of video, transcripts, workbook, certificate,
and 12 templates in Word and Excel. Self-paced, with no expiry.
€629.00
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