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Coles Mastering Safety Risk Management for Medical and Vitro Devices at Bayshore Shopping Centre in Ottawa, ON
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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).
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).
Coles is renowned for its outstanding customer service and great selection of books. Along with the vast array of magazines, stationary, audio-books, children's literature, fiction, non-fiction and reference books, you can find accessories to make your reading experience more pleasurable. We can recommend the very best in reading today. We will help you search our titles for exactly what you need, and if we do not have it in stock, we will order it for you.
