Summative Evaluation Pack (EN 62366-1:2015/A1:2020 standard)
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The two essential templates for designing, conducting, and documenting your summative evaluation according to standard EN 62366-1:2015/A1:2020.
Structure your study rigorously, ensure traceability with your risk analysis, and produce a solid and defensible dossier for a CE auditor.
A complete, ready-to-use pack, designed to save you time without compromising on quality.
Ready-to-use structure to save time
Designed by usability experts
Practical Advice and Integrated Examples
The EN 62366 summative evaluation packincludes the two central documents for your usability validation:
- The summative evaluation protocol,
- The summative evaluation report.
This pack allows you to:
- Define a robust and defensible methodology,
- Select and justify scenarios related to hazardous phenomena,
- Justify that use-related risks have been evaluated,
- Prepare your test sessions,
- Structure the presentation of results in a clear and traceable manner.
The two templates are designed to work together, with a consistent traceability logic between: risk analysis → scenario selection → protocol → results.
The structure reflects the expectations actually observed during CE audits (MDR/IVDR), while integrating best practices from FDA and HE75 guidance.
This allows you to focus on your methodological choices and your device, without spending hours structuring your documents.
Written by usability specialists who have supported more than 50 medical device manufacturers, this pack combines regulatory rigor and practical pragmatism.
A 15-minute videoconference with one of our experts is included to help you get started with the templates: understand their structure, color codes, and filling logic. (This session does not include specific advice or support for the device.)
This pack includes:
- Summative Evaluation Protocol
Document to:
- Describe how use-related risks will be evaluated,
- Document user testing methodology,
- Structure your tests.
2.Summative Evaluation Report
Document to:
- Recall the methodology,
- Present the results of your evaluation clearly and understandably,
- Ensure traceability between risks, scenarios, and results.
Each section is enriched with concrete examples, practical advice, and points of attention to facilitate adaptation to your own device.
- Structure your usability validation in a robust and consistent manner, from protocol to final report.
- Ensure traceability between risk analysis, evaluated scenarios, and documented results.
- Secure your compliance with clause 5.9 of EN 62366-1.
- Clarify your methodological choices for CE (MDR/IVDR) auditors.
- Save several days of writing thanks to a directly usable template.
- Document your results clearly, professionally, and defensibly.
- Rely on a structure inspired by actually audited files.
- Reduce the risk of inconsistencies between protocol and report.
- Maintain control over your content, without relying on external support.
- Benefit from a 15-min video conference with an expert to quickly master the logic of the models and gain autonomy.
Compatibility
- Microsoft Word
- Google Docs (Word recommended for optimal display)
Language
Depending on the variant selected
License Type
Internal use only
Delivery
Immediate download after payment
Updates
Included for 12 months
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.
