Safety Risk Management for Medical Devices

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).

Great reference for anyone in medical device industry

I have the first edition of this gem and highly recommend it for any professionals in the medical device space wanting to learn practical methods of applying and implementing the state-of-the-art requirements of product safety risk management. A must have to improve your processes and gain insight into the art and science of risk management!

The book itself is okay. Not great, but a good resource.The buying experience was bad. The delivery was several days late after multiple "running late" alerts. Then when it was finally delivered, the book cover had multiple scratches and bends. Has Amzon unlearned how to ship books properly? Sometimes I receive box inside box deliveries for items that are not fragile at all, but it seems that books are now shipped in buble wrap envelopes that create lots of damage during shipping. Maybe we should all go back to our local bookstores if our Amazon book orders will take a week to be delivered anyway and will be damaged. Prime is not worth its cost anymore.