{"product_id":"mastering-safety-risk-management-medical-vitro-devices-9781636941707-new","title":"Mastering Safety Risk Management for Medical and In Vitro Devices","description":"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).","brand":"ASQ QUALITY PR","offers":[{"title":"New","offer_id":67613448339746,"sku":"9781636941707-new","price":65.88,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0893\/4755\/5618\/files\/9781636941707.jpg?v=1793090828","url":"https:\/\/www.albakireads.com\/products\/mastering-safety-risk-management-medical-vitro-devices-9781636941707-new","provider":"AlbakiReads","version":"1.0","type":"link"}