Customer Reviews

Reliable Design of Medical Devices

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This book provides a solid reference for the Systems Engineer who is working on a medical device, including for IVD devices. The book is specifically structured to cover the design process and important documentation requirements in order to meet FDA 510(k) submissions. It also introduces the more typical reliability design process approach used in other industries such as telecommunications, to the design of medical devices.

The chapters of the book develop many areas of the engineering design process specific to biotechnology. The book covers the important area of 14971 Risk Assessment requirements and how this standard impacts the engineering design process. The book provides good ideas for incorporating 14971 into the standard engineering design process.

The book is useful for both medical devices (60601 requirements) as well as providing guidance for IVD devices. It lists many references for the medical systems engineer. I highly recommend it as a reference book.