IEC 62366: Usability Engineering Process, File and Evidence
IEC 62366 is built on one uncomfortable idea: a patient can be seriously harmed while every component of the device performs exactly as specified. The…
MD Regulatory Blog
Design Control
Design Control
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ISO 13485 Design Controls: Requirements and Design History File
The ISO 13485 design control requirements are where most small and medium medical device manufacturers fail their first certification audit. Clause 7.3 of ISO 13485:2016…
