---
product_id: 365938713
title: "Safety Risk Management for Medical Devices"
price: "€ 186.67"
currency: EUR
in_stock: true
reviews_count: 6
url: https://www.desertcart.pt/products/365938713-safety-risk-management-for-medical-devices
store_origin: PT
region: Portugal
---

# Safety Risk Management for Medical Devices

**Price:** € 186.67
**Availability:** ✅ In Stock

## Quick Answers

- **What is this?** Safety Risk Management for Medical Devices
- **How much does it cost?** € 186.67 with free shipping
- **Is it available?** Yes, in stock and ready to ship
- **Where can I buy it?** [www.desertcart.pt](https://www.desertcart.pt/products/365938713-safety-risk-management-for-medical-devices)

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## Description

Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on 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 practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. Includes new coverage of ISO 14971:2019, ISO/TR 24971 Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation

Review: Complete step by step approach for implementing effective risk management solutions - The book Safety Risk Management for Medical Devices, beautifully articulates the process of risk management in conformance to ISO 14971. More than just theory, it provides step-by-step instructions on the risk management process. This book is easy to read and offers not just clarity on how to identify and quantify risk, but also gives excellent advice on how to bring real value to the product development process. The provided templates and the complete example of a risk management file in Appendix C is an excellent resource, especially as the file has been reviewed by the FDA (US) and BSI (UK).
Review: Well written excellent book - Great reference for anyone in medical device industry

## Technical Specifications

| Specification | Value |
|---------------|-------|
| Best Sellers Rank | #1,656,957 in Books ( See Top 100 in Books ) #232 in Biomedical Engineering #5,651 in Technology (Books) #95,187 in Textbooks (Special Features Stores) |
| Customer Reviews | 4.3 out of 5 stars 16 Reviews |

## Images

![Safety Risk Management for Medical Devices - Image 1](https://m.media-amazon.com/images/I/717AwNehixS.jpg)

## Customer Reviews

### ⭐⭐⭐⭐⭐ Complete step by step approach for implementing effective risk management solutions
*by L***N on May 2, 2022*

The book Safety Risk Management for Medical Devices, beautifully articulates the process of risk management in conformance to ISO 14971. More than just theory, it provides step-by-step instructions on the risk management process. This book is easy to read and offers not just clarity on how to identify and quantify risk, but also gives excellent advice on how to bring real value to the product development process. The provided templates and the complete example of a risk management file in Appendix C is an excellent resource, especially as the file has been reviewed by the FDA (US) and BSI (UK).

### ⭐⭐⭐⭐⭐ Well written excellent book
*by E***S on September 9, 2022*

Great reference for anyone in medical device industry

### ⭐⭐⭐⭐⭐ An Excellent Book on Safety Risk Mgmt.
*by K***M on December 22, 2024*

Bijan, I have been reading your book this holiday break, and I can’t start to express my gratitude for writing such an excellent text. As you know, it seldom happens in academia that a textbook is both accessible and readable. Thank you for spending all those lonely hours writing this book. I hope our paths cross again soon.

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*Product available on Desertcart Portugal*
*Store origin: PT*
*Last updated: 2026-06-24*