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How and When to Conduct Your First Hazard Analysis

A session by Sarah Nixon
Quality Engineer, Rook Quality Systems

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About this session

This presentation will begin with a discussion of why a Hazard Analysis is important to the risk management process outlined in ISO 14971:2019. The Hazard Analysis should begin at the same time the design control process begins to allow potential harms identified to be addressed as the design develops. This presentation will then detail how the first Hazard Analysis should be completed, including an overview of the hazard categories identified in ISO 14971:2019 that should be addressed.

  1. “Why is hazard analysis important? The Hazard Analysis helps determine at an early stage the major risks of your device to the patient and user. The documentation of the hazard analysis helps inform design decisions to improve safety and usability as well as identifying your testing requirements.

  2. Understanding why you should start the hazard analysis early on in the design and development process and how it informs your design controls

  3. Understanding the hazard analysis process as per ISO 14971:2019

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