Cover Mastering Safety Risk Management for Medical and In Vitro Devices

Leseprobe

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Leseprobe

Mastering Safety Risk Management for Medical and In Vitro Devices

Name: Mastering Safety Risk Management for Medical and In Vitro Devices
Author: Jayet Moon, Arun Mathew

Jayet Moon, Arun Mathew

EPUB

ca. 69,99 €

Amazon iTunes Thalia.de Hugendubel Bücher.de ebook.de kobo Osiander Google Books Barnes&Noble bol.com Legimi yourbook.shop Kulturkaufhaus ebooks-center.de
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ASQ Quality Press

Sozialwissenschaften, Recht, Wirtschaft / Wirtschaft

Beschreibung

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).

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