Medical-Device Usability: Human Factors for Medical Device Development [Hardcover]

This book simplifies the process regarding the application of usability to medical devices for new developers by providing a thought-out walkthrough of what is involved and how the expectations from the essential standards affect their work and why.?

Chapter 1: What to Know Before Getting Started Chapter 2: Usability Engineering Chapter 3: Usability Toolbox Chapter 4: Medical-Device Documentation Chapter 5: Clinical Environment Chapter 6: Benefit Management Chapter 7: Practical Transparency Chapter 8: Listening to the User Chapter 9: Integration with Quality Management Chapter 10: The Metro Map Chapter 11: Seeing into the Future Chapter 12: Conformity Assessment Chapter 13: Business as Usual Chapter 14: Conclusions

This book simplifies the process regarding the application of usability to medical devices for new developers by providing a thought-out walkthrough of what is involved and how the expectations from the essential standards affect their work and why. Based on the authors experiences, the information in the book provides other more seasoned experts with a wealth of insight and nuggets of new perspectives on addressing the usability of medical devices, particularly medical software.

The discussion in the book is rooted in recent real-world experiences from both the manufacturer and assessment body sidesthe authors provide a novel high-level roadmap to using usability engineering to guide development activities from initial conceptual design to research, development, and ultimately release of a medical device. They build toward this map throughout the book and ultimately present the full model. This roadmap is the result of the authors experiences of taking a research project and launching both a medical device and a medical device business after obtaining all the necessary reglC,