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Summative Evaluation Report (EN 62366-1:2015/A1:2020)

Summative Evaluation Report (EN 62366-1:2015/A1:2020)

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189,00 €
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Summative Evaluation Report (EN 62366-1:2015/A1:2020)
  • Summative Evaluation Report (EN 62366-1:2015/A1:2020)
  • Summative Evaluation Report (EN 62366-1:2015/A1:2020)
  • Summative Evaluation Report (EN 62366-1:2015/A1:2020)
  • Summative Evaluation Report (EN 62366-1:2015/A1:2020)
  • Summative Evaluation Report (EN 62366-1:2015/A1:2020)
  • Summative Evaluation Report (EN 62366-1:2015/A1:2020)
Summative Evaluation Report (EN 62366-1:2015/A1:2020)

Summative Evaluation Report (EN 62366-1:2015/A1:2020)

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189,00 €
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A complete, structured, and ready-to-use template for writing your summative evaluation report according to CE marking requirements and standard EN 62366-1:2015/A1:2020.

Each section guides you step-by-step with concrete examples, practical advice, and key points for easy adaptation to your own device.

Present your test results clearly, traceably, and aligned with the expectations of CE auditors.

Ready-to-use structure to save time

Designed by usability experts

Practical Advice and Integrated Examples

Detailed Description

This template guides you step-by-step in writing your summative evaluation report, based on standard EN 62366-1:2015/A1:2020 and the actual expectations of auditors for CE marking.

It is based on clause 5.9 of the standard, incorporating best practices from FDA and HE75 guidance, to offer a clear and immediately usable structure.

The summative evaluation report is a key component of the usability file: it demonstrates, with supporting evidence, the use safety of your device.

With the Aptenys template, you can focus on content and analysis, without wasting time trying to structure your document.

The framework has been designed to reflect industry standards and be compatible with MDR/IVDR requirements, while remaining clear, modern, and directly usable.

This template allows you to:

  • Save considerable writing time,
  • Structure your results in a consistent and professional manner,
  • Highlight your evaluation evidence clearly and convincingly.

Designed by usability specialists who have supported more than 50 medical device manufacturers, this template combines regulatory rigor, pragmatism, and clarity of presentation.

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

This template includes the following sections:

  1. Introduction
  2. Executive Summary
  3. Presentation of the Mechanism
  4. Methodology Summary
  5. Results
  6. Root Cause Analysis
  7. Conclusion
  8. Appendices 

Each section includes concrete examples, practical advice, and key considerations to facilitate adaptation to your own mechanism.
Why choose this template

  • Save several days of work thanks to a ready-to-fill and directly operational structure.
  • Focus on your methodological choices, without spending hours interpreting the standard or searching for the right organization of sections.
  • Rely on a robust framework, built on the EN 62366-1 logic and enriched with FDA/HE75 best practices.
  • Benefit from a proven framework, inspired by more than 100 protocols written and defended by usability experts.
  • Optimize the clarity of your deliverables: a fluid, logical, and easily understandable presentation for auditors.
  • Access practical advice and concrete examples for each section.
  • Ensure traceability between risk analysis, protocol, results, and final report, whether for MDR or IVDR.
  • Enjoy a 15-minute video conference with an expert to quickly master the logic of the model and gain autonomy.
Technical Specifications

Format
  • PDF
  • DOCX

Number of pages / tabs

51

File size

341 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.