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Oct 23, 2024
  • Seminar

Open Forum: Use Related Risk Analysis Q&A

A session dedicated to answering your questions about conducting and documenting use related risk analyses.

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Date & Time

Starts

Oct 23, 2024 9:00am CST

Ends

10:00am CST

Location

Online

Language

English

Conducting a use related risk analysis (URRA) is one of the most important steps when applying a human factors engineering (HFE) process during development of your medical device or combination product. This is understandable noting your goal is to develop a product that is safe and effective to use. Your risk analysis will be key in determining if you achieve this objective. Whether it’s helping determine user interface requirements, the scope of your HF validation efforts, or whether the device has acceptable residual risk, the URRA is the foundation for your most critical HFE activities. Given its importance, it’s no wonder there are often questions amongst teams when it comes to performing this key activity. Let us help you with some of those questions.

During this session, we expect to share our insights on questions regarding such use related risk analysis topics as:

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Strategies for starting a URRA
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Comparison of risk analysis processes (e.g., URRA vs. use-FMEA)
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Linkages between the URRA and usability testing
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Regulatory expectations for URRAs (e.g., FDA guidance, ISO 14971)

What you learn during this session though will depend on the questions you and your fellow attendees ask.

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