What You Will Learn
At the end of this workshop, you will be able to:
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Describe the usability requirements in quality management system standards and regulations (IEC 62366-1:2020, ISO 13485:2016, ISO 14971:2019, EU IVDR Annex I, FDA)
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Provide an analysis of the requirements of the IEC 62366-1:2020
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Illustrate the interactions between risk management and usability engineering
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Practice documenting potential failure modes in usability and their effects
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Describe the links between design usability, risk management, and complaints
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Establish examples of traceability among user-related hazards, risk mitigations, product requirements, and verification / validation results
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Determine procedures and evidence needed to demonstrate compliance to usability requirements in IEC 62366-1:2020 and related standards / regulations
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Evaluate best practices in usability elements of premarket submissions
Who Should Attend
Anyone from the medical device and in vitro diagnostic device industry involved in development, including regulatory personnel. Recommended for staff with the specific responsibility of risk management, as well as quality engineering, technical services, operations, QA/QC, regulatory, and research and development.
Course Days
Virtual Class Days: 5 days, Monday - Friday daily 1:00 - 5:00 p.m.
Classes run either on Eastern Time or Central European Time as indicated in the virtual class "Location" field
Virtual Half-Days:
5
In-Person Full-Days:
3
CEUs:
2.4