- Raising awareness among a broad audience of the fundamentals (CE marking, vigilance, MDR roles) without committing several days
- Preparing an audience for a more demanding in-person course (prior upskilling)
- Reviewing key concepts ahead of an audit, a certification, a project
- Training a geographically dispersed audience when organising an in-house session is cumbersome
E-learning
Medical device e-learning training
Short, self-paced modules to get started quickly, at your own pace. A complement to inter-company and in-house training, not a substitute.
Our e-learning offering is under construction. It will grow throughout the year. For immediate needs, inter-company and in-house remain the most complete formats.
Why an e-learning format at ISOFAC GROUP
E-learning is not suited to everything. Building an ISO 13485 QMS, conducting an internal audit, structuring a technical file requires group practice and feedback from a trainer. These courses remain in person or in a virtual classroom.
E-learning is relevant for:
We therefore offer short modules (1 to 4 hours), self-paced, with an assessment quiz. No 30-hour “MOOC” impossible to finish.
Available modules
Our e-learning catalogue grows progressively. Modules under construction are flagged “Coming soon”. You can sign up for the launch alert for each one.
Coming soon Duration: 2 h
Discovering the MDR 2017/745 regulation
For newcomers to the MD sector or support functions (sales, non-specialist quality, purchasing). Understand the actors, CE marking, risk classes. Final 20-question quiz.
Alert me at launch → Coming soon Duration: 2 h
Discovering the IVDR 2017/746 regulation
Specific to IVDs. Classes A to D, the role of health institutions (Article 5(5)), manufacturer obligations. Final quiz.
Alert me at launch → Coming soon Duration: 1 h 30
Understanding the MDR roles: manufacturer, authorized representative, importer, distributor
Identify your role and your obligations within the supply chain. Particularly useful for European distributors and importers. Final quiz.
Alert me at launch → Coming soon Duration: 1 h
Introduction to vigilance and PMS
Overview of post-market surveillance, incidents and FSCAs. For support audiences. Final quiz.
Alert me at launch → Coming soon Duration: 3 h
Preparing for your ISO 13485 audit
Pre-audit module for operational teams. Understand what an auditor will look for, what needs to be prepared, the common pitfalls. Final quiz.
Alert me at launch →ISOFAC GROUP e-learning teaching format
Typical structure of a module
- Introductory video (2 to 5 minutes) setting the context and objectives
- Thematic video capsules (5 to 10 minutes each) with slides, voice-over and transcription
- Downloadable reference documents (summary, checklists, glossary)
- Self-assessment mini-quiz at the end of each chapter
- Final validation quiz (15 to 25 questions, 70% pass threshold)
- Downloadable certificate upon success
Quality commitment
- Content written and updated by Thomas Trullen and Jonathan Bedin
- Updated at every major regulatory development (new MDCG, new guidance)
- Last-updated date visible on each module
- Sources explicitly cited (regulation article, MDCG, standard)
- No marketing content disguised as training
Access terms
| Item | Detail |
|---|---|
| Audience | Anyone wishing to understand the MD fundamentals. No prerequisites unless otherwise stated in the module sheet. |
| Access | Online purchase or via a training agreement for companies. Immediate access after payment (account created automatically). Access duration: 6 months from enrolment. You can resume where you left off. Compatible with computer, tablet, smartphone. |
| Pricing (to be confirmed) | Single module: price indicated on each sheet (typically €50 to €200 excl. tax). Team package: from 10 users, degressive pricing. Training agreement available for OPCOs and skills development plans. |
| Disability accessibility | Subtitles on all videos. Text transcription available. For persons with disabilities requiring a specific accommodation, contact our disability officer [TO BE COMPLETED]. |
| E-learning results indicators | To be published once trainee volumes allow for reliable statistics. |
| Certification | Certificate of achievement (if the 70% threshold is reached on the final quiz) or certificate of completion (if the module is completed without passing the quiz). |
E-learning, inter-company, in-house: how to combine them
Case 1 — Broad awareness-raising for a team
E-learning recommended. All employees access the same basic content, at their own pace. Controlled cost.
Case 2 — A new Quality Manager or regulatory affairs lead taking up their role
E-learning first (core MDR modules), then in-depth in-person training (Building a QMS, Internal Auditor). E-learning serves as upskilling.
Case 3 — Preparing for an ISO 13485 certification or MDR CE marking
A mix: awareness e-learning for support teams, in-house in-person training for the actors directly involved. Coherent, economical.
Case 4 — Qualifying internal auditor training
In-person only. Auditing requires role-play and feedback from experience that do not translate into e-learning.
Frequently asked questions
ISOFAC GROUP is in the process of obtaining Qualiopi certification. Once obtained, it will cover all training activities, including e-learning. The number and scope will be displayed explicitly.
Yes, provided ISOFAC GROUP is Qualiopi-certified and your OPCO accepts the format. We provide the necessary elements (detailed programme, pricing, certificate) for your application.
For the first version, the modules are in French. An English version is being considered for the most requested modules (core MDR, EC REP).
6 months from enrolment. This period amply covers the needs of self-paced learning, including with interruptions linked to your activity.
You can retake it up to 3 times within your initial access. Beyond that, new access is required.
Yes. From 10 users, degressive pricing applies. You get an administrator area to track your team's progress (modules started, modules completed, quiz scores).
Want to be informed when the modules launch?
Leave us your email address. We will notify you each time a new e-learning module goes live, with no commercial follow-ups.
Talk to us →See also: Training catalogue · Inter-company & In-house