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You already have a usability engineering file, but want to know whether it's truly compliant with IEC 62366-1 expectations and solid enough to be defended.
I carry out global IEC 62366-1 compliance audits, with a structured, clause-by-clause review of the file. For each applicable requirement, the audit specifies the compliance level, an associated explanation, missing or weak elements, and recommended actions.
The goal: a clear view of the file's compliance, priority gaps identified, and a realistic action plan.
Audit my IEC 62366-1 fileIn brief
Clause-by-clause audit, compliance level, explanations and prioritized recommendations.
You want to assess its IEC 62366-1 compliance, or check its overall consistency after being built up gradually.
Audit, submission, certification, file update, or you've received questions from a notified body.
Identify priority gaps before relaunching a study, or assess the impact of a modification on the existing file.
The audit helps distinguish genuinely critical points from minor documentation adjustments, and prioritize the actions to take.
The audit isn't just about checking that documents exist. It assesses the coherence of the process against IEC 62366-1: intended use, users, environment of use, use-related risk analysis, evaluation scenarios, results, traceability and the link to risk management.
Each applicable requirement is reviewed with a compliance level and an associated explanation. Gaps are put in context to distinguish genuinely critical points from minor documentation adjustments.
A useful audit isn't just about ticking boxes: it explains what's compliant, weak, or needs strengthening.
Clause-by-clause IEC 62366-1 audit grid
Compliance level per requirement
Explanation associated with each compliance level
Identification of gaps and weak points
Prioritized recommendations
Upgrade action plan
Summary usable by RAQA, R&D or leadership teams
Each applicable requirement is linked to a compliance level, an explanation and, where needed, a prioritized recommendation.
01
Understanding the product, users, regulatory context and existing elements.
02
Building, auditing or completing the necessary elements based on need.
03
Providing usable deliverables and recommendations teams can understand.
Let's review your existing deliverables and the actions to prioritize.
Let's discuss your audit