Application of Risk Analysis Techniques in Jama to Satisfy ISO 14971

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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. Today, many medtech companies are using spreadsheets to capture risk data and in so doing are then faced with the manual process of somehow connecting that information to design and mitigation. Achieving medical software and hardware compliance is much less stressful when developers and stakeholders have a structured, detailed and easy-to-use data information management process in place.


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