{"product_id":"mastering-safety-risk-management-for-medical-and-in-vitro-devices-paperback","title":"Mastering Safety Risk Management for Medical and In Vitro Devices - Paperback","description":"\u003cdiv\u003e\u003cp style=\"text-align: right;\"\u003e\u003ca href=\"https:\/\/reportcopyrightinfringement.com\/\" target=\"_blank\" rel=\"nofollow\"\u003e\u003cb\u003eReport copyright infringement\u003c\/b\u003e\u003c\/a\u003e\u003c\/p\u003e\u003c\/div\u003e\u003cp\u003eby \u003cb\u003eJayet Moon\u003c\/b\u003e (Author), \u003cb\u003eArun Mathew\u003c\/b\u003e (Author)\u003c\/p\u003e\u003cp\u003eWhen 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).\u003c\/p\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003eNumber of Pages:\u003c\/strong\u003e 306\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003eDimensions:\u003c\/strong\u003e 0.64 x 9 x 6 IN\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003ePublication Date:\u003c\/strong\u003e May 10, 2024\u003c\/div\u003e\n            ","brand":"Books by splitShops","offers":[{"title":"Default Title","offer_id":52606145134874,"sku":"9781636941707","price":100.8,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1005\/5604\/6618\/files\/uYeEegGBDj9781636941707.webp?v=1785322896","url":"https:\/\/j-s-five-and-dime.myshopify.com\/products\/mastering-safety-risk-management-for-medical-and-in-vitro-devices-paperback","provider":"J \u0026 S Five and Dime","version":"1.0","type":"link"}