About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

Risk assessment involves describing the relationships between a hazard (a potential source of harm) and the ultimate consequences in terms of physical injury or damage. For some devices, non-physical injury, such as psychological harm, should also be considered. As part of their risk assessment, manufacturers should analyze possible sequences of events, hazardous situations, and associated possible harm. This may include:

  • initiating hazards, failure modes, or circumstances;
  • the sequences of events that could lead to a hazardous situation occurring;
  • the likelihood of such situations arising;
  • the likelihood that the hazardous situations lead to harm; and
  • the nature of the harm that could result.

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