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With our quick guide, you can implement the usability process in compliance with IEC 62366-1, avoid costly rounds of revisions and pass the MDR and FDA audit with confidence.
Many manufacturers fail their audits due to an incomplete usability dossier, or only discover serious design flaws shortly before launch. The result:
A concise overview of the key legislation (MDR, IVDR, DiGAV, FDA) and standards (IEC 62366-1, ISO 14971)
We’ll guide you through the four stages – from user research to summative evaluation.
Find out why supporting documentation is part of the user interface and how to avoid duplication in your documentation.
We provide practical advice on planning resources, budgets and user testing.
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