Resources — UserWise, LLC

Document
2023 \| FDA Draft Guidance Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format ︎
2022 \| FDA Draft Guidance Content of Human Factors Information in Medical Device Marketing Submissions ︎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 ︎
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2018 \| FDA Draft Guidance Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications ︎
2018 \| FDA Draft Guidance Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications ︎
2017 \| FDA Draft Guidance Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA ︎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2016 \| FDA Draft Guidance Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development ︎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 ︎

Document

2023 | FDA Draft Guidance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2022 | FDA Draft Guidance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 ︎

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2018 | FDA Draft Guidance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 ︎

2017 | FDA Draft Guidance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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UserWise offers a wide range of services spanning the product development cycle. Our consultants assist in performing user research, constructing the use-related risk analysis, conducting formative evaluations, executing summative usability validation testing, refining user manuals, compiling the Usability Engineering File and FDA Human Factors/Usability Engineering Submission Report, and so much more.

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