Mastering Safety Risk Management for Medical and In Vitro Devices (eBook)

Jayet Moon, Arun Mathew (Autoren)

eBook Download: PDF

2024
304 Seiten
Asq Quality Press (Verlag)
978-1-63694-171-4 (ISBN)

Infos

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). 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).

Produkt-Details

• Erscheint lt. Verlag: 10.5.2024
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Gesundheitswesen
• Themenwelt: Recht / Steuern ► Wirtschaftsrecht
• Themenwelt: Technik
• Themenwelt: Wirtschaft ► Betriebswirtschaft / Management ► Rechnungswesen / Bilanzen
• Schlagworte: risk management, ISO 13485:2016, ISO 14971:2019, medical device manufacturing
• ISBN-10: 1-63694-171-0 / 1636941710
• ISBN-13: 978-1-63694-171-4 / 9781636941714