Services/IEC 62366-1 Audit
IEC 62366-1 AUDIT · FDA HUMAN FACTORS · 60601-1-6
You already have a usability file and want to assess its compliance with IEC 62366-1, FDA Human Factors expectations and, where applicable, EN 60601-1-6, as well as its overall consistency and the points that need strengthening.
I carry out global compliance audits, with a structured, clause-by-clause review of the file against the applicable standard(s). For each requirement, the audit specifies the level of compliance, the associated explanation, any missing or weak elements, and the recommended actions.
The goal: gain a clear view of the file's compliance, identify priority gaps, and have a realistic action plan.
Clause-by-clause audit, compliance level (IEC 62366-1, FDA HF, 60601-1-6), explanations and prioritised recommendations.
WHO IT'S FOR
You want to assess its compliance with the applicable standards (IEC 62366-1, FDA Human Factors, EN 60601-1-6), or check its overall consistency after being built up progressively.
You're preparing a submission, a certification, a file update, or a response to questions from a notified body.
Identify priority gaps before relaunching a study, or assess the impact of a change on the existing file.
The audit helps distinguish genuinely critical points from minor documentation tweaks, and prioritise the actions to take.
WHAT I BRING
The audit doesn't just check whether documents exist. It assesses the consistency of the process against the applicable standards: intended use, users, use environment, use-related risk analysis, evaluation scenarios, results, traceability and the link with risk management.
Each applicable requirement is assigned a compliance level and an explanation. Gaps are put in context to distinguish critical points, substantive inconsistencies and minor documentation tweaks.
A useful audit doesn't just tick boxes: it explains what is compliant, weak or in need of strengthening.
Each applicable requirement is assigned a compliance level, an explanation and, where needed, a prioritised recommendation.
Illustrative example - actual IEC 62366-1 clauses, statuses and comments provided for demonstration purposes.
| Clause | Requirement | Level | Finding and recommended action |
|---|---|---|---|
| 4.1.1 | Usability engineering process | Compliant | Process documented and consistent with IEC 62366-1. No action required. |
| 5.1 | Establish the use specification | Partially compliant | Specification present, but the environment is incomplete. Complete the representative conditions of use. |
| 5.3 | Identify foreseeable hazards and hazardous situations | Non-compliant | Hazard analysis missing. Carry out the use-related hazard analysis as a priority. |
| 5.9 | Conduct the summative usability evaluation of the user interface | Not applicable | Not required at this stage of development. To be revisited before submission. |
What can be included
Clause-by-clause IEC 62366-1 audit checklist · Compliance level per requirement · Explanation for each compliance level · Identification of gaps and weak points · Prioritised recommendations · Upgrade action plan · Summary usable by RAQA, R&D or management teams
METHOD
01
Define the applicable standard, the documentation scope, the device's context and the objective of the review.
02
Analyse the deliverables, assign a compliance level, and document gaps, inconsistencies and missing elements.
03
Present the results, explain the recommendations, and build a prioritised action plan.
Let's review your existing deliverables and the actions to prioritise.
Get your file audited