Aptenys provides methodological templates designed by Usarea, a consultancy specializing in usability and medical devices, to help you structure your deliverables with rigor and regulatory compliance.
Ready to use with built-in advice
Designed and used by experts
10+ years of expertise
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Select the template(s) suitable for your project. Each template is structured according to the EN 62366 standard and designed for immediate use.
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After your order is confirmed, you will instantly receive a secure download link to access your documents.
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Customize the documents according to your device and context of use. The templates guide you but do not, on their own, guarantee regulatory compliance.
Structured templates to properly frame your usability approach, without overlooking the key elements expected by authorities.
You start from a proven base rather than a blank document or incomplete old templates. You can focus on the content without wasting time on the format.
Each template incorporates best practices from real-world CE/FDA projects, with advice and examples directly embedded.
"Advance efficiently and calmly on your usability assessment files."
We created Aptenys to help you structure your regulatory deliverables quickly and with confidence.
Thanks to proven and readily usable templates, you save time while meeting MDR and IVDR requirements.
Aptenys supports your quality, regulatory, and R&D teams in producing clear, reliable, and easily defensible documents for auditors.
Templates designed by usability specialists
Immediate access to documents
after payment validation
100% secure payment by credit card
Have a question? Our team
will get back to you within 48 hours
The templates are designed based on regulatory requirements and expected audit practices.
They provide a solid and structured foundation, to be adapted to your system, risks, and usage context to ensure final compliance.
No. The license only permits internal use. Any use for third parties, external sharing, or resale is prohibited without written agreement.
Yes. The templates are provided in fully editable formats, so you can freely adapt them to your organization, processes, and systems.
Yes, when they are properly adapted and integrated into your file.
They reflect the expectations observed in audits and provide a clear methodological framework. As with any regulatory document, their acceptance depends on the overall consistency of your file and the regulatory context of your device.
Yes. The Usarea teams can support you in addition to the templates, whether in your usability, design, or user research approach.
You can contact us at contact@usarea.fr to discuss your needs.
