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Glossary Term
Harm & Hazard Analysis (ISO 14971)
Definition
Harm and hazard analysis is a systematic process outlined in ISO 14971, the international standard for medical device risk management. This process identifies potential hazards associated with a medical device, assesses the associated risks, and evaluates the likelihood of harm occurring to patients, users, or the environment. It is a critical part of ensuring device safety and regulatory compliance.
Relevance to the MedTech Industry
Harm and hazard analysis ensures that medical devices are designed, manufactured, and used with minimal risks to health and safety. By proactively identifying and mitigating risks, manufacturers protect end-users, enhance product reliability, and meet regulatory requirements.
Additional Information & Related Terms
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