Safety Risk Management for Medical Devices guides the reader through the performance of risk management activities in a way that is compliant with the requirements of the international standard ISO 14971. Focusing exclusively on the safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practice. Common uncertainties associated with the interpretation of international standards are also explored. Opening chapters introduce the concept of risk, review the relevant international standards and give an overview of risk management process metrics and the relevance of human factors and biocompatibility. The next group of chapters introduces risk management techniques. Detailed treatments of different parts of the risk management process then follow, from risk estimation to post-launch surveillance and clinical trials. Written with practicing engineers, safety management professionals and students in mind, this book will help readers to comprehend the language of risk management, know how to declare that risks have been reduced to the lowest possible level and establish effective risk acceptance criteria. Teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971Removes uncertainties associated with the understanding and application of international standards, e.g. ISO 14971Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation INDICE: 1. Understanding Risk 2. Risk Management International Standards 3. Risk Management Process Metrics 4. Human Factors and Risk Analysis 5. Biocompatibility and Risk Analysis 6. Risk Analysis Techniques 7. Software Risk Analysis 8. Risk Estimation 9. Risk Evaluation 10. Risk Controls 11. Influence of Security on Safety 12. Risk Benefit Analysis 13. On Testing 14. Postmarket Surveillance 15. Clinical Investigation 16. Advice and Wisdom
- ISBN: 978-0-12-813098-8
- Editorial: Academic Press
- Encuadernacion: Rústica
- Páginas: 350
- Fecha Publicación: 01/06/2018
- Nº Volúmenes: 1
- Idioma: Inglés