Medical Device Design - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Medical Device Design write by . This book was released on 2012-12-17. Medical Device Design available in PDF, EPUB and Kindle. This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products
Handbook of Human Factors in Medical Device Design
Handbook of Human Factors in Medical Device Design - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Handbook of Human Factors in Medical Device Design write by Matthew Bret Weinger. This book was released on 2010-12-13. Handbook of Human Factors in Medical Device Design available in PDF, EPUB and Kindle. Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance
Medical Device Design and Regulation
Medical Device Design and Regulation - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Medical Device Design and Regulation write by Carl T. DeMarco. This book was released on 2011-01-01. Medical Device Design and Regulation available in PDF, EPUB and Kindle.
Applied Human Factors in Medical Device Design
Applied Human Factors in Medical Device Design - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Applied Human Factors in Medical Device Design write by Mary Beth Privitera. This book was released on 2019-06-15. Applied Human Factors in Medical Device Design available in PDF, EPUB and Kindle. Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation. Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU) Explains technology development and the application of human factors throughout the development process Covers FDA and MHRA regulations Includes case examples with each method
Contextual Inquiry for Medical Device Design
Contextual Inquiry for Medical Device Design - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Contextual Inquiry for Medical Device Design write by Mary Beth Privitera. This book was released on 2015-05-29. Contextual Inquiry for Medical Device Design available in PDF, EPUB and Kindle. Contextual Inquiry for Medical Device Design helps users understand the everyday use of medical devices and the way their usage supports the development of better products and increased market acceptance. The text explains the concept of contextual inquiry using real-life examples to illustrate its application. Case studies provide a frame of reference on how contextual inquiry is successfully used during product design, ultimately producing safer, improved medical devices. Presents the ways contextual inquiry can be used to inform the evaluation and business case of technology Helps users understand the everyday use of medical devices and the way their usage supports the development of better products Includes case studies that provide a frame of reference on how contextual inquiry is successfully used during the product design process
