Usability engineering file synthesis (EN 62366-1:2015/A1:2020 standard)

The summary of the usability engineering file is a key document in your regulatory documentation.

It allows you to demonstrate, in a structured way, that all the requirements of standard EN 62366-1 have been correctly taken into account, documented, and applied throughout the device development cycle.

This Aptenys template has been designed to allow you to:

• Structure the overall narrative of your defensible usability approach during CE audits,
• Demonstrate full coverage of clauses 5.1 to 5.9 of EN 62366-1,
• Ensure consistency between risk analysis, formative evaluations, summative evaluation, and results,
• Save considerable time when preparing the final file,
• Facilitate the reading and understanding of the file by auditors and notified bodies.

The framework follows the logic recommended by guide TR 62366-2:2016 and the requirements of EN 62366-1:2015/A1:2020, while integrating practical expectations from CE audits, MDR/IVDR requirements, and best practices from international guidance.

Each section includes:

• Drafting examples,
• Practical advice,
• Clearly identified points of attention,

to guide you without unnecessarily burdening the document.

This template has been deliberately designed as a summary: it explicitly refers to source documents (risk analyses, protocols, reports, PMS, etc.) and is not intended to replace them.

This allows you to present a clear, legible, and coherent file, while maintaining detailed and complete documentation in your usability engineering file.

Written by usability specialists who have supported more than 50 medical device manufacturers, this template reflects the practices actually expected in the field, and not a mere theoretical reading of the standard.

A 15-minute videoconference with one of our experts is included to 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.)