Usability Strategy Pack (EN 62366-1:2015/A1:2020 standard)
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A complete kit to structure and frame your usability engineering process according to standard EN 62366-1:2015/A1:2020.
This pack brings together the essential documents for planning, integrating, and auditing your usability approach within the framework of CE marking (MDR/IVDR).
Lay solid foundations, even before drafting your protocols and reports.
Ready-to-use structure to save time
Designed by usability experts
Practical Advice and Integrated Examples
The EN 62366 usability strategy pack bringsthe together three complementary models to help you structure your usability approach from the very first phases of development.
It helps you to:
- Frame the integration of the usability process into your quality system,
- Formalize activity planning,
- Anticipate and verify the conformity of your dossier with regulatory requirements.
This pack is particularly suitable for:
- Manufacturers preparing for their first CE marking,
- Quality teams wishing to formalize their process,
- Organizations in the structuring or internal audit phase,
- Companies preparing for a review by a notified body.
The two included plans can be integrated into your technical file and submitted to a notified body, provided they are properly adapted to your device and your organization.
Each model is structured according to the logic of standard EN
62366-1:2015/A1:2020 and compatible with MDR and IVDR requirements.
Written by usability specialists who have supported more than 50 medical device manufacturers, this kit 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 models: understanding their structure, color codes, and filling logic. (This session does not include specific advice or support for the device.)
This pack includes:
- Usability Engineering Process Integration Plan
Document to:
- Describe how the EN 62366 process is integrated into the development cycle,
- Ensure consistency with the quality management system,
- Clarify responsibilities and key steps.
2. User Interface Evaluation Plan
Structuring document defining:
- The formative and summative evaluation strategy,
- The articulation with risk analysis.
3. EN 62366 Compliance Audit Grid
Practical tool for:
- Planning the steps to be carried out and documents to be produced,
- Verifying the completeness of your file,
- Identifying discrepancies before audit,
- Ensuring traceability with normative clauses.
Each section includes concrete examples, practical advice, and points of attention to facilitate adaptation to your own device.
- Structure your usability approach before entering into studies.
- Secure your compliance with EN 62366-1 requirements.
- Clarify your methodological choices for CE auditors.
- Save several days of work on initial structuring.
- Avoid critical omissions in your file.
- Benefit from a logic aligned with ISO 14971.
- Rely on templates inspired by actually audited files.
- Maintain control of your content, without relying on external support.
- Benefit from a 15-minute video conference with an expert to quickly master the logic of the templates and gain autonomy.
Compatibility
- Microsoft Word
- Google Docs (Word recommended for optimal viewing)
- Microsoft Excel
- Google Sheets (advanced Excel features recommended)
Language
Depending on the selected variant. Please note, for the French pack: the audit grid is in English
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.
