Product Overview
Design History File and Standards Documentation
The engineering side of a regulatory submission, built together with the device instead of reconstructed at the end. We prepare the design history file, design inputs and outputs, ISO 14971 risk management inputs including fault tree analysis, verification plans and reports, test software, and the technical documentation for 510(k), De Novo, PMA and EU MDR 2017/745 packages.
We design and document to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62304, IEC 62366-1, ISO 14971, ISO 10993-1 and IEC 62133-2, and to the security standards FDA recognizes for health software. Accredited laboratories run the formal tests, and the regulatory strategy and submission stay with you or your regulatory consultant.
Our group's quality management system is certified to ISO 13485:2016 (certificate 044-25, held by Canyon Medical Inc., valid to October 13, 2028). $125 per hour.
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