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).
| Autorius: | Arun Mathew, Jayet Moon, |
| Leidėjas: | ASQ Quality Press |
| Išleidimo metai: | 2024 |
| Knygos puslapių skaičius: | 306 |
| ISBN-10: | 1636941702 |
| ISBN-13: | 9781636941707 |
| Formatas: | Knyga minkštu viršeliu |
| Kalba: | Anglų |
| Žanras: | Management accounting, bookkeeping and auditing |
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