Mastering Safety Risk Management for Medical and In Vitro Devices

When it comes to medical and in vitro devices, risk management starts with a design assurance process...
€132,07 EUR
€132,07 EUR
SKU: 9781636941707
Product Type: Books
Please hurry! Only 399 left in stock
Author: Jayet Moon
Format: Paperback
Language: English
Subtotal: €132,07
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Mastering Safety Risk Management for Medical and In Vitro Devices by Moon, Jayet

Mastering Safety Risk Management for Medical and In Vitro Devices

€132,07

Mastering Safety Risk Management for Medical and In Vitro Devices

€132,07
Author: Jayet Moon
Format: Paperback
Language: English
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).

Author: Jayet Moon, Arun Mathew
Publisher: ASQ Quality Press
Published: 05/10/2024
Pages: 306
Binding Type: Paperback
Weight: 0.91lbs
Size: 9.00h x 6.00w x 0.64d
ISBN: 9781636941707

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