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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:[...]opean Union MDR, IVDR, and US FDA regulations (including the
new FDA QMSR).
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:[...]opean 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:[...]opean Union MDR, IVDR, and US FDA regulations (including the
new FDA QMSR).
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:[...]opean Union MDR, IVDR, and US FDA regulations (including the
new FDA QMSR).
Details
Erscheinungsjahr: | 2024 |
---|---|
Fachbereich: | Allgemeines |
Genre: | Wirtschaft |
Rubrik: | Recht & Wirtschaft |
Medium: | Taschenbuch |
ISBN-13: | 9781636941707 |
ISBN-10: | 1636941702 |
Sprache: | Englisch |
Ausstattung / Beilage: | Paperback |
Einband: | Kartoniert / Broschiert |
Autor: | Moon, Jayet |
Hersteller: | ASQ Quality Press |
Maße: | 229 x 152 x 17 mm |
Von/Mit: | Jayet Moon |
Erscheinungsdatum: | 10.05.2024 |
Gewicht: | 0,446 kg |
Details
Erscheinungsjahr: | 2024 |
---|---|
Fachbereich: | Allgemeines |
Genre: | Wirtschaft |
Rubrik: | Recht & Wirtschaft |
Medium: | Taschenbuch |
ISBN-13: | 9781636941707 |
ISBN-10: | 1636941702 |
Sprache: | Englisch |
Ausstattung / Beilage: | Paperback |
Einband: | Kartoniert / Broschiert |
Autor: | Moon, Jayet |
Hersteller: | ASQ Quality Press |
Maße: | 229 x 152 x 17 mm |
Von/Mit: | Jayet Moon |
Erscheinungsdatum: | 10.05.2024 |
Gewicht: | 0,446 kg |
Warnhinweis