ISO 14971 Basic Concepts – Hazard, Hazardous Situation and Harm
Exeed Regulatory Compliance
FEBRUARY 24, 2020
3) Harm In the context of safety risk management under ISO 14971, harm is defined as injury or damage to the health of people, or damage to property or the environment. One good resource is MedDRA, or Medical Dictionary for Regulatory Activities. It is a very broad definition.
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