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.
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
The course follows the sequence of the work rather than the numbering of the regulation, and ends where the work ends.
Introduction
Course scope and how it worksDesign and development of medical device software
Design controls under the MDRIEC 62304
Lifecycle processes, safety classification, SOUP, maintenanceIEC 82304-1
Health software product requirementsFinal test
Covering the whole courseOutcomes
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.
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. Access does not expire, and revisions made after your purchase are included.
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.
Certificate
Verifiable by a third party
On passing the final test, the certificate carries a verification 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 your quality system.
MDR-XXXX-XXXX · mdregulatory.com/verify
Questions
Before you enrol
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 included with the course 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.
That list maps to the templates in the Software Documentation Kit, Software Documentation Kit Gold.
Enrol
Software V&V
4 modules, 2h 30 of video, downloadable transcripts, workbook and certificate. Self-paced, with no expiry.