Article | February 7, 2018

Application Of Risk Analysis Techniques In Jama To Satisfy ISO 14971

Source: Jama Software

By Jama Software


Medical technology companies, especially those developing medical devices, are faced with a wide range of techniques for managing risk. The hardest part is often deciding which specific techniques and data points need to be captured to demonstrate that all angles of risk analysis for the product have been accounted for. ISO 14971 is a harmonized standard (now superseding EN 1441) that provides a comprehensive approach to reducing risk to the lowest reasonable level. The Jama Software product development platform gives teams following ISO 14971 a single source of data and robust information management. This article looks at  how Jama has helped customers navigate various risk techniques including FMEA to satisfy ISO 14971.