Posts tagged Hazard definition

ISO 14971 Basics – Using a PHA for Risk Analysis

Risk analysis is a key requirement of ISO 14971:2019, the recently revised International Standard for Risk Management of Medical Devices. As outlined in Clause 5.1, the manufacturer shall perform risk analysis for the particular medical device as described in clauses 5.2 to 5.5. Here is how a Preliminary Hazard Analysis (PHA) can help.

Regulatory Compliance, Product QualityNaveen AgarwalOctober 5, 2020ISO 14971 Basic Concepts, ISO 14971:2019, ISO 14971, Understanding ISO 14971:2019, Risk management for medical devices, Risk Management, PHA, preliminary hazard analysis, Hazard definition, Hazardous situation definition, Risk analysis conceptsComment

ISO 14971 Basic Concepts – Hazard, Hazardous Situation and Harm

These terms are foundational to risk analysis, yet they are poorly understood and often incorrectly applied.