Jayet Moon

Jayet Moon

Jayet Moon

A consulter en ligne

Affiche du document Mastering Safety Risk Management for Medical and In Vitro Devices

Mastering Safety Risk Management for Medical and In Vitro Devices

Jayet Moon

1h52min30

  • Bourse et finance
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  • Livre epub
  • Livre lcp
150 pages. Temps de lecture estimé 1h52min.
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).
 Accès libre
Affiche du document Mastering Safety Risk Management for Medical and In Vitro Devices

Mastering Safety Risk Management for Medical and In Vitro Devices

Jayet Moon

3h48min45

  • Bourse et finance
  • Youscribe plus
305 pages. Temps de lecture estimé 3h49min.
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).
 Accès libre

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