{"product_id":"mastering-safety-risk-management-for-medical-and-in-vitro-devices","title":"Mastering Safety Risk Management for Medical and In Vitro Devices","description":"\u003cp\u003eBy Jayet Moon, Arun Mathew 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). Product Details ASIN ‏ : ‎ B0D5FYMLL3 Publisher ‏ : ‎ ASQ Quality Press (10 May 2024) Language ‏ : ‎ English\u003c\/p\u003e","brand":"Public Health","offers":[{"title":"Default Title","offer_id":48959455166638,"sku":null,"price":27.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0765\/8179\/8062\/files\/41bVhFbcmBL._SX342_SY445_QL70_ML2_-1.jpg?v=1787953460","url":"https:\/\/ebooksmedical.com\/products\/mastering-safety-risk-management-for-medical-and-in-vitro-devices","provider":"Ebooks Medical","version":"1.0","type":"link"}