Begin Your Risk Analysis with Intended Use and Foreseeable Misuse

One of the challenges in risk analysis of medical devices is the diversity of use scenarios based on the target medical purpose and use environments. That is why ISO 14971:2019, the recently revised International Standard for Risk Management of Medical Devices, requires that risk analysis begin with a clear understanding of the intended use and reasonably foreseeable misuse.

Risk Management, Regulatory ComplianceNaveen AgarwalOctober 12, 2020ISO 14971 Basic Concepts, ISO 14971:2019, ISO 14971, Understanding ISO 14971:2019, Risk analysis concepts, risk analysis, intended use, forseeable misuseComment