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FDA & ISO Issued Documentation

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FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices (2016) ︎
ISO 14971: Application of risk management to medical devices (2019) ︎
FDA Draft Guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (2016) ︎
IEC 62366-1: Application of usability engineering to medical devices (2020) ︎

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