The video follows the structure of your IFU

Each scene covers one step, in the words of the IFU.

  • One step, one chapter

    Each step of the IFU becomes a chapter of the video: users go straight back to the step they need to redo.

  • Warnings on screen

    Every check and every warning in the IFU appears at the moment of the step it concerns.

  • One film per user profile

    Patient at home or biomedical technician: vocabulary and environment change, and the film follows your use specification.

  • Frozen versions for your evaluations

    Numbered versions and a referenced script: the video goes into your formative and summative evaluations, run by your teams or your provider.

One critical step, seen from the front, then from the side

The demo shows pad placement on a fictional defibrillator. On a front-view diagram, as in an IFU, the lateral pad easily ends up too far forward; the side view shows where it goes, below the armpit. With the pad pictograms of five manufacturers, laypeople most often placed it too far forward: a documented use error, which the authors suggest preventing with a side view (Nurmi and Castrén, 2005).

Device
Fictional defibrillator, drawn for the demo
Step
Pad placement, step 3 of a fictional IFU
Length
28 s, silent
Sources
Nurmi and Castrén, Resuscitation 2005; Resuscitation Council UK, 2025
Animated demo on a training manikin: pad 2 of a fictional defibrillator placed on the side, below the armpit
Fictional device and IFU, created for this demonstration: these are not instructions for use. Real instructions come from the manufacturer's validated documentation.

Frozen before your evaluations, reworked when the IFU changes

A step is learnt at launch, then learnt again after feedback from the field.

Before your evaluations: when training is part of what you evaluate, the video is ready and frozen before the summative evaluation.

At launch: training the first patients and the first healthcare professionals, in hospital and at home.

After feedback from the field: a complaint concerns a step, and the video reworks that step, alongside the measures you decide.

When the IFU changes: only the scenes of the modified steps are redone.

For a new market: the video in the country's language, based on that country's IFU.

Every sentence of the script points to a page of your IFU

Our sources are yours: instructions for use, use specification and, if you share it, use-related risk analysis with its use scenarios, under a confidentiality agreement. The justification file gives the page and exact passage for every sentence and, when the analysis is shared, links each scene to its line; your teams approve each version.

  1. 01

    Scoping, in 30 minutes

    Objective, audience, where the video will be shown, available references and regulatory points to watch.

  2. 02

    The referenced script

    Every line is tied to a reference, with its page and the exact passage that supports it.

  3. 03

    The visuals

    Motion design and medical animation, with AI assisting part of the production. Diagrams remain illustrations.

  4. 04

    Checks and delivery

    An automated check finds every passage, word for word, on the page cited; two independent AI-assisted audits then re-check a sample in the documents; your review committee, or your MLR review in a pharmaceutical company, approves the final version.

The justification file, in detail
Animation: one line of a fictional use-related risk analysis, the IFU sentence it points to, the scene that shows it, then the version frozen for the summative evaluation and the update after feedback from the field
From one line of your risk analysis to the scene, then to the version frozen for the summative evaluation. Fictional analysis, IFU and device, created for this demonstration.

What you receive

Every deliverable states the IFU version it is based on.

  • The film and its broadcast files

    Landscape for your website, YouTube and the training room; portrait, square or 4:5 for social media.

  • Subtitles and transcript

    SRT file and full text: accessibility, viewing without sound and search visibility for the page that hosts the film.

  • The script and the justification file

    Every line, its reference, its page and the exact passage, ready for your internal review.

  • The bibliographic references

    The full list, in order of appearance, with links to the public sources.

  • The versions you need

    Short excerpts, stills, a poster or slides, depending on your channels. Quoted with the final version.

  • Languages

    The languages you choose: every translated line keeps its source and exact passage, and the rules of the country where the video is shown are checked at scoping.

See how every video adapts to your needs

See how a film follows your brand guidelines

The Regulation puts training after design and protection

Regulation (EU) 2017/745 sets an order of priority: eliminate or reduce risks through design, then take protection measures, and finally provide information for safety and, where appropriate, training to users (Annex I, section 4). Against use errors, the manufacturer takes into account the technical knowledge, experience, education and training of users (Annex I, section 5). A video therefore helps users follow the IFU; it does not correct a design flaw. Kept as a risk control measure in your risk management (ISO 14971), its effectiveness is verified with users, in your usability engineering process (IEC 62366-1). Faithful to the IFU and free of claims, a correct-use video falls outside advertising under the rules of the French agency, the ANSM.

Frequently asked questions

Does the video comply with IEC 62366-1?
The standard describes the manufacturer's usability engineering process and certifies no material. To date it is not in the list of harmonised standards under Regulation (EU) 2017/745 (European Commission list of 17 June 2026), unlike EN ISO 14971: it therefore gives no presumption of conformity. The video is designed to fit your process, with its sources cited and frozen versions.
Can you start from our use-related risk analysis?
Yes, under a confidentiality agreement if you wish. Without it, we start from the IFU and its warnings.
Who tests the video with users?
Your teams or your usability provider, in your formative or summative evaluations. We deliver the numbered versions and the test files.
Can the video replace the IFU?
No, it adds to it. The legal detail is on our Medical device video page.
Is a training video advertising?
Faithful to the IFU, free of claims and given to those who use the device, it falls outside advertising under the French ANSM rules, like training manuals and demonstrations of use. As soon as it promotes the product, advertising rules apply.
And for an FDA submission?
The FDA human factors guidance (revised 3 August 2026) counts training materials as part of the user interface under evaluation. It asks for them to be finalised before validation testing, and for the training given to participants to match what real users will receive, with time between training and test. We deliver the video frozen and numbered for that test; the FDA does not accept “additional training” as an answer without data showing its effect.

The step where your users go wrong, animated in a few days

Describe it in a few lines. After a 30-minute call and a read of your IFU, we make a first version of 60 seconds at most, before any quote.