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Design History File

Digital Design Control for Medical Devices

Medical Device companies have to manage complexity and regulation without placing excess overhead on their designers. Devices complexity has led to increased complaints, CAPAs, observations, and recalls. The root cause is frequently insufficient and cumbersome design control. Digitalization helps them design with agility while maintaining control. It improves speed, accuracy, and productivity by automating submissions,…

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  • Tech-Clarity TV

Jim Brown - February 20, 2018 - Filed Under: Presentations & Videos, Tech-Clarity TV, Video - Tagged With: Design History File, Siemens PLM, DHF, Quality, FDA, CAPA, Med Device, Device Master Record, Digital Enterprise, DMR, Digital Design, Medical Device, Digital Design Control, Traceability, Submissions, Compliance, Vlog, Observations, Tech-Clarity TV, Digitalization, Recalls, Video, Product Innovation Platform, Innovation

Does Quality Management Belong in PLM? (eBook)

The Does Quality Belong in PLM? eBook explores the value of implementing quality management processes in a Product Lifecycle Management system. The research shares perspectives from several manufacturers about managing quality processes like CAPA and creating product documentation including Design History Files (DHF) and Design Master Records (DMR). The eBook looks at the value of using standalone Quality…

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  • eBooks

Jim Brown - August 8, 2016 - Filed Under: Published Research, eBooks - Tagged With: Design History File, DHF, Design Master Record, PLM, QMS, Quality Management, Product Lifecycle Management, DMR, Top Ten, Quality Risk Management, Quality System

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