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User Interface Evaluation Plan (EN 62366-1:2015/A1:2020)

User Interface Evaluation Plan (EN 62366-1:2015/A1:2020)

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$35.00 USD
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User Interface Evaluation Plan (EN 62366-1:2015/A1:2020)
  • User Interface Evaluation Plan (EN 62366-1:2015/A1:2020)
  • User Interface Evaluation Plan (EN 62366-1:2015/A1:2020)
  • User Interface Evaluation Plan (EN 62366-1:2015/A1:2020)
  • User Interface Evaluation Plan (EN 62366-1:2015/A1:2020)
  • User Interface Evaluation Plan (EN 62366-1:2015/A1:2020)
  • User Interface Evaluation Plan (EN 62366-1:2015/A1:2020)
User Interface Evaluation Plan (EN 62366-1:2015/A1:2020)

User Interface Evaluation Plan (EN 62366-1:2015/A1:2020)

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$35.00 USD
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A clear, structured, and immediately actionable template for defining your formative and summative evaluation strategy according to standard EN 62366-1:2015/A1:2020.

Ideal for structuring your evaluations from the start of the project, without wasting time building a structure from scratch.

Ready-to-use structure to save time

Designed by usability experts

Practical Advice and Integrated Examples

Detailed Description

This template guides you in drafting a User Interface Evaluation Plan, a document expected in any usability engineering process compliant with EN 62366-1:2015/A1:2020.

It clearly and operationally describes:

  • How formative and summative evaluations integrate into development,
  • How methods are selected,
  • How interfaces will be tested and documented,
  • And how results will feed into risk management and design.

Thanks to this Aptenys template, you benefit from a solid structure, inspired by real projects and aligned with current regulatory practices. This allows you to focus on your methodological decisions, without spending hours assembling requirements scattered throughout the standard.

This template is particularly useful when preparing a CE file.

It was designed by usability specialists who have supported more than 50 medical device manufacturers.

A 15-minute video conference with one of our experts is included for getting started with the template: understanding its structure, its color codes, and its filling logic.
(This session does not include specific advice or support for the device.)
Template content

This template includes the following sections:

  1. Introduction
  2. Device overview
  3. Evaluation overview
  4. Life cycles covered
  5. Formative evaluations
  6. Summative evaluation
  7. Traceability to use-related risks
  8. High-level timeline

Each section includes concrete examples, practical tips, and points of attention to facilitate adaptation to your own device.
Why choose this template

  • Save several hours of work with a clear, structured, and ready-to-fill template.
  • Focus on your methodological choices rather than normative interpretations.
  • Rely on a robust structure, aligned with EN 62366-1, for both MDR and IVDR.
  • Facilitate traceability between requirements, risks, protocols, and results.
  • Benefit from practical advice to draft a document that is both precise and operational.
  • Take advantage of a proven template, designed by usability experts.
  • Benefit from a 15-minute video conference with an expert to quickly master the logic of the model and gain autonomy.

 
Technical Specifications

Format
  • DOCX
  • PDF

Number of pages / tabs

34

File size

644 KB

Compatibility
  • Microsoft Word
  • Google Docs (Word recommended for optimal viewing)

Language

Depending on the selected variant

License Type

Internal use only

Delivery

Immediate download after payment

Updates

Included for 12 months
License and Terms of Use

This template is copyrighted and intended for internal use only. Any reproduction, resale, distribution, or adaptation for commercial purposes is strictly prohibited without prior authorization from Aptenys™.

This template is sold as methodological support but does not alone guarantee regulatory compliance.

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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.