How it works

It's simple.

1

Choose your template

Select the model(s) or bundle that matches your needs.

2

Finalize your order

Secure online payment. The templates are 100% digital products.

3

Instant Download

You will receive a download link allowing you to access your files (Word / Excel / PowerPoint PDF formats depending on the template).

4

Complete and submit

Each template is structured and guided (advice, points of attention, examples) to allow for quick adaptation to your device

Resources That Truly Make a Difference

Templates designed for teams that want quality without wasting time. Each template adapts to your context, device, and methodological choices.

✓ Structure your usability deliverables

✓ Meet regulatory requirements by being guided in the expected drafting

✓ Save time without sacrificing rigor

Based on

EN 62366-1 or FDA guidances

Expected practices during audits

Years of experience

To be 100% transparent

Here's what our templates do not do:

✗ Ensure the regulatory compliance of your device

✗ Obtain an auditor's report or an opinion from the competent authority

✗ Replace a regulatory analysis / field study

✗ Be "turnkey," ready to submit without adaptation.

You are given a solid methodological foundation, but you are in charge. The responsibility for final adaptation and compliance remains with the manufacturer.

License & Terms of Use

License Type

The purchase of an Aptenys model grants an non-exclusive, non-assignable, and non-transferable internal use license to the purchasing entity.

⚠️ What is prohibited without our consent:

Reselling, distributing, and sharing with third parties

Use for commercial purposes for external clients

Provision to partners, subcontractors, subsidiaries and external consultants

Any reproduction or distribution, even partial, including:

screenshots,
excerpts from sections,
copies of pages,
distribution on training materials, presentations, internal or external platforms,
publication on collaborative tools or shared spaces accessible to third parties outside the purchasing entity.