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FDA & ISO Issued Documentation


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2023 | FDA Draft Guidance 
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format ︎
2022 | FDA Draft Guidance
Content of Human Factors Information in Medical Device Marketing Submissions ︎
2020 | 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 ︎
2019 | ISO 14971
Application of risk management to medical devices
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2018 | 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2018 | FDA Draft Guidance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2018 | FDA Draft Guidance
Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications ︎
2017 | FDA Draft Guidance
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA ︎
2016 | 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2016 | FDA Draft Guidance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
 
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