Frequently Asked Questions
Do the templates ensure regulatory compliance?
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.
May I use a template for a client, resell it, or share it?
No. The license only permits internal use. Any use for third parties, external sharing, or resale is prohibited without written agreement.
Can I modify the templates?
Yes. The templates are provided in fully editable formats, so you can freely adjust them to your organization, processes, and systems.
Are templates accepted in an audit?
Yes, when properly adapted and integrated into your documentation.
They reflect the expectations observed during audits and provide a clear methodological framework. As with any regulatory document, their acceptance depends on the overall consistency of your documentation and the regulatory context of your device.
Do you offer additional support?
Yes. Usarea's teams can assist you in addition to the templates, whether it's for your usability approach, design, or user research.
You can contact us at contact@usarea.fr to discuss your needs.