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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: | Importe, Wirtschaft |
| Rubrik: | Recht & Wirtschaft |
| Medium: | Taschenbuch |
| ISBN-13: | 9781636941707 |
| ISBN-10: | 1636941702 |
| Sprache: | Englisch |
| Einband: | Kartoniert / Broschiert |
| Autor: |
Moon, Jayet
Mathew, Arun |
| Hersteller: | ASQ Quality Press |
| Verantwortliche Person für die EU: | Libri GmbH, Europaallee 1, D-36244 Bad Hersfeld, gpsr@libri.de |
| Maße: | 229 x 152 x 17 mm |
| Von/Mit: | Jayet Moon (u. a.) |
| Erscheinungsdatum: | 10.05.2024 |
| Gewicht: | 0,446 kg |
Details
| Erscheinungsjahr: | 2024 |
|---|---|
| Fachbereich: | Allgemeines |
| Genre: | Importe, Wirtschaft |
| Rubrik: | Recht & Wirtschaft |
| Medium: | Taschenbuch |
| ISBN-13: | 9781636941707 |
| ISBN-10: | 1636941702 |
| Sprache: | Englisch |
| Einband: | Kartoniert / Broschiert |
| Autor: |
Moon, Jayet
Mathew, Arun |
| Hersteller: | ASQ Quality Press |
| Verantwortliche Person für die EU: | Libri GmbH, Europaallee 1, D-36244 Bad Hersfeld, gpsr@libri.de |
| Maße: | 229 x 152 x 17 mm |
| Von/Mit: | Jayet Moon (u. a.) |
| Erscheinungsdatum: | 10.05.2024 |
| Gewicht: | 0,446 kg |
Sicherheitshinweis