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Resource Library

FDA & ISO Issued Documentation


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FDA Draft Guidance: Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (2023) ︎
FDA Draft Guidance: Content of Human Factors Information in Medical Device Marketing Submissions (2022) ︎
IEC 60601-1-6 Ed. 3.2 (2010 + A1:2013 + A2:2020): Application of usability engineering to medical devices (2020) ︎
IEC 62366-1 (2015)/Amd 1: Application of usability engineering to medical devices (2020) ︎
ISO 14971: Application of risk management to medical devices (2019) ︎
ANSI/AAMI HE75 (2009)/R2018: Human Factors Engineering - Design of Medical Devices (2018) ︎
FDA Draft Guidance: Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications (2018) ︎
IEC 62366-2: Medical Devices — Part 2: Guidance on the Application of Usability Engineering to Medical Devices (2016) ︎
FDA Draft Guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (2016) ︎
FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices (2016) ︎
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Our consultants partner with medical device companies to fulfill any and all steps of the Usability Engineering Process.

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