OEM Risk Management: ISO 14971: Guidance for Medical Devi

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Dive into the comprehensive yet concise reference guide on risk management for medical devices. This essential book on ISO 14971 stands out as the globally recognized standard for medical device risk management. The author, Beverly White, expertly outlines the fundamental terms and key regulations from various global health authorities. Perfect for industry professionals seeking to enhance their understanding of risk analysis and management techniques. At 126 pages, this softcover book is an invaluable resource for anyone in the medical device field.

Unlock the vital knowledge surrounding risk management in the medical device industry with 'Risk Management: ISO 14971: Guidance for Medical Devices' by Beverly White. This expertly curated reference not only offers a concise overview of ISO 14971 but delves deeply into the essential definitions, general requirements, and pertinent regulations from influential entities including the FDA and Health Canada. The book serves as a pivotal resource for understanding how to navigate the complexities of medical device risk management amidst evolving global standards. Within its pages, you will find detailed discussions on various risk analysis techniques including Fault Tree Analysis, FMEA, and Preliminary Hazard Analysis. Each method is broken down clearly, allowing for both novices and seasoned professionals to grasp the concepts effectively. Moreover, White emphasizes the importance of management roles and planning in the risk management process, making this guide a comprehensive tool for any professional looking to elevate their practice. Whether you're preparing for an audit, developing a new product, or enhancing your risk management strategies, this book is your go-to source to ensure compliance and excellence within the medical device landscape.

Usage ideas This book is ideal for professionals involved in medical device development, regulatory affairs, quality assurance, and risk management. It's perfect for risk managers, compliance officers, engineers, and healthcare consultants looking to familiarize themselves with ISO standards. Additionally, it serves as an excellent reference for academic courses on medical device regulation and management. Use it as a foundational tool for training sessions or as a daily reference in your workplace for compliance best practices.

Frequently asked questions
Is this book suitable for beginners?: Yes, this guide is written in a clear and accessible manner, making it suitable for both newcomers and experienced professionals in the industry.
Does the book cover international regulations?: Absolutely! It discusses regulations from various global health authorities including the FDA, Health Canada, and the European Union.
Can I use this book for risk management training?: Definitely. It's a great resource for training sessions on ISO standards and risk management strategies.

- Brand: OEM
- Condition: New
- Model: B09NRG1HM6
- SKU: B09NRG1HM6
- Length (cm): 1
- Width (cm): 15
- Height (cm): 23
- Weight (kg): 0.24
- Language: English
- Title: Risk Management: ISO 14971: Guidance for Medical Devi
- Author: White, Beverly
- Cover Type: Softcover
- Page Count: 126

Vendor listing title: Libro: Risk Management: Iso 14971: Guidance For Devi