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Your Privacy Choices

How does it work? It's simple.

1

Choose Your Template

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

2

Finalize your order

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

3

Immediate 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 model is structured and guided (tips, points of attention, examples) to allow for quick adaptation to your system.

When specified on the product sheet, a getting started session is offered to explain the document's logic.

Support Materials That Really Make a Difference

Templates designed for teams that want quality without wasting time

Structure your deliverables

With Structured Templates for Usability

Comply with regulatory requirements

You are guided in the expected drafting

Save time

Without sacrificing rigor

Designed to be

Clear

Educational

Exploitable

Adaptable

Based on

EN 62366-1 or FDA guidance

expected audit practices

years of experience

💡 Each template adapts to your context, your device, and your methodological choices.

To be 100% transparent

Here's what our templates do not do:

Ensuring the Regulatory Compliance of Your Device

Formulate an auditor's opinion or competent authority's opinion

Replace a regulatory analysis or a field study

To be "turnkey", ready to submit without adaptation.

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

License & terms of use

License Type

Internal use license: non-exclusive, non-assignable, and non-transferable. This is for you, not for your neighbor.

⚠️ The following are prohibited without our consent:

  • Resale, dissemination, and sharing with third parties
  • Commercial use for external clients
  • Disclosure to partners, subcontractors, subsidiaries and external consultants
  • Any reproduction or distribution, even partial, including:
    screenshots,
    section excerpts,
    page copies,
    distribution on training materials, presentations, internal or external platforms,
    publication on collaborative tools or shared spaces accessible to third parties external to the purchasing entity.

Okay to modify

The templates can be modified and
adapted freely for internal use,
to meet the specific needs of the
device concerned, but they remain protected
by copyright.

Copyright

All templates remain protected by
copyright.

The full terms of use are detailed in the GTC and the license agreement associated with the templates.