Reviews
"This book is a comprehensive overview of all the pieces that need to come together to bring a medical device from an idea to an approved device. It is an impressive compilation of information that is not easily found elsewhere, and included extensive references for every chapter. The writing is clear, yet succinct. The book is well organized with labeled subsections that let the reader find exactly what content he/she may want to explore. Each chapter has exercises that can be used as a self-assessment or to supplement a class." --Anna Iwaniec Hickerson, Keck Graduate Institute of Applied Life Sciences, Claremont, California, USA, "This book is a comprehensive overview of all the pieces that need to come together to bring a medical device from an idea to an approved device. It is an impressive compilation of information that is not easily found elsewhere, and included extensive references for every chapter. The writing is clear, yet succinct. The book is well organized with labeled subsections that let the reader find exactly what content he/she may want to explore. Each chapter has exercises that can be used as a self-assessment or to supplement a class." --Anna Iwaniec Hickerson, Keck Graduate Institute of Applied Life Sciences, Claremont, California, USA "The risk management process section of this text will be very valuable to a capstone design class where teams will likely need to implement strategies to mitigate risks in the development and execution of their design projects. While risk estimation may not be feasible to attempt in an academic design course due to the limited scope and duration, this section offers the reader excellent exposure to analyses such as FMEA that are commonly used in industry." --Shelly Gulati, University of the Pacific, Stockton, California, USA mited scope and duration, this section offers the reader excellent exposure to analyses such as FMEA that are commonly used in industry." --Shelly Gulati, University of the Pacific, Stockton, California, USA, "This book is a comprehensive overview of all the pieces that need to come together to bring a medical device from an idea to an approved device. It is an impressive compilation of information that is not easily found elsewhere, and included extensive references for every chapter. The writing is clear, yet succinct. The book is well organized with labeled subsections that let the reader find exactly what content he/she may want to explore. Each chapter has exercises that can be used as a self-assessment or to supplement a class." --Anna Iwaniec Hickerson, Keck Graduate Institute of Applied Life Sciences, Claremont, California, USA "The risk management process section of this text will be very valuable to a capstone design class where teams will likely need to implement strategies to mitigate risks in the development and execution of their design projects. While risk estimation may not be feasible to attempt in an academic design course due to the limited scope and duration, this section offers the reader excellent exposure to analyses such as FMEA that are commonly used in industry." --Shelly Gulati, University of the Pacific, Stockton, California, USA
