The Failure of Risk Management: Why It's Broken and How to Fix It 2nd Edition Douglas W. Hubbard
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Mastering Safety Risk Management for Medical and In Vitro Devices
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- Engelsk
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Økonomi & Business
When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product’s life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).
© 2024 ASQ Quality Press (E-bog): 9781636941721
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E-bog: 10. maj 2024
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