FMEA-Med® - Failure Modes & Effects Analysis for Medical Device and BiopharmaFMEA-Med® is desktop software solution that helps individual users more efficiently conduct Failure Mode and Effects Analysis. FMEA-Med helps medical device and pharmaceutical manufacturers better analyze product designs and manufacturing processes, shorten the time it takes to conduct risk assessments and achieve more thorough FMEAs. Currently in Version 8 and available as a single-user license, FMEA-Med improves quality, productivity and safety while providing a means for reviewing product and process designs and ensuring compliance with regulations and standards. FMEA-Med® is available in Asia Pacific via EnVizTec’s partner agreement with Sphera, the market leader in Operational Risk Management. FeaturesPre-formatted Industry Standards - Design and Process FMEA; Hazards and Error Analysis; Healthcare FMEA; Functional, Software, Interface, and Detailed FMEA; and Process Mapping. Regulatory Compliance - FMEA-Med helps organizations with the implementation of their company-wide quality, risk, and reliability programs based on regulations and standards including:
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