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

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

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$319.00 USD
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Summative Evaluation Protocol (Standard EN 62366-1:2015/A1:2020)
  • Summative Evaluation Protocol (Standard EN 62366-1:2015/A1:2020)
  • Summative Evaluation Protocol (Standard EN 62366-1:2015/A1:2020)
  • Summative Evaluation Protocol (Standard EN 62366-1:2015/A1:2020)
  • Summative Evaluation Protocol (Standard EN 62366-1:2015/A1:2020)
  • Summative Evaluation Protocol (Standard EN 62366-1:2015/A1:2020)
  • Summative Evaluation Protocol (Standard EN 62366-1:2015/A1:2020)
Summative Evaluation Protocol (Standard EN 62366-1:2015/A1:2020)

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

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$319.00 USD
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A complete, structured, and ready-to-use template for drafting your summative evaluation protocol in accordance with CE marking requirements and standard EN 62366-1:2015/A1:2020. 

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

Save time, without compromising on rigor and quality.  

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 through the drafting of your summative evaluation protocol, based on standard EN 62366-1:2015/A1:2020 and on practices genuinely expected during CE audits.

Structured according to clause 5.9, and enhanced with approaches recommended in FDA and HE75 guidance, it allows you to easily build a robust and fully usable protocol.

The summative evaluation protocol is one of the central documents in your usability file: it defines the methodology, participant profiles, usage scenarios evaluated, success criteria, and all the modalities necessary for a solid and defensible study.

With the Aptenys template, you can focus on the content and your methodological choices, without wasting hours trying to figure out how to structure your sections.

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 therefore allows you to:

  • Significantly reduce preparation time,
  • Structure your evaluation choices clearly and professionally,
  • Ensure traceability between risks, scenarios, and test objectives.

Written by usability specialists who have supported more than 50 medical device manufacturers, this template combines regulatory rigor with practical pragmatism.

A 15-minute video conference with one of our experts is included to help you get started with the template: understanding its structure, color codes, and 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. Methodology
  4. Definition of risks and selection of use scenarios related to the hazard
  5. Assessment activities
  6. Appendices

Each section includes concrete examples, practical advice, and points of attention to facilitate adaptation to your own device.
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 section organization.
  • Rely on a robust framework, built on EN 62366-1 logic and enriched with FDA/HE75 best practices.
  • Benefit from a proven framework, inspired by over 100 protocols written and defended by usability experts.
  • Optimize the clarity of your deliverables: 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 model's logic and gain autonomy.

 
Technical Specifications

Format
  • DOCX
  • PDF

Number of pages / tabs

51

File size

336 KB

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

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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Summative Evaluation Protocol (Standard EN 62366-1:2015/A1:2020)
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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.