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Synopsis

This book explains all of the stages involved in developingmedical devices; from concept to medical approval including systemengineering, bioinstrumentation design, signal processing,electronics, software and ICT with Cloud and e-Healthdevelopment. 

Medical Instrument Design and Development offers a comprehensivetheoretical background with extensive use of diagrams, graphics andtables (around 400 throughout the book). The book explains how thetheory is translated into industrial medical products using amarket-sold Electrocardiograph disclosed in its design by the GammaCardio Soft manufacturer.

The sequence of the chapters reflects the product developmentlifecycle. Each chapter is focused on a specific University courseand is divided into two sections: theory and implementation. Thetheory sections explain the main concepts and principles whichremain valid across technological evolutions of medicalinstrumentation. The Implementation sections show how the theory istranslated into a medical product.  The Electrocardiograph(ECG or EKG) is used as an example as it is a suitable device toexplore to fully understand medical instrumentation since it issufficiently simple but encompasses all the main areas involved indeveloping medical electronic equipment. 

Key Features:

  • Introduces a system-level approach to product design
  • Covers topics such as bioinstrumentation, signal processing,information theory, electronics, software, firmware, telemedicine,e-Health and medical device certification
  • Explains how to use theory to implement a market product (usingECG as an example)
  • Examines the design and applications of main medicalinstruments
  • Details the additional know-how required for productimplementation: business context, system design, projectmanagement, intellectual property rights, product life cycle,etc.
  • Includes an accompanying website with the design of thecertified ECG product (www.gammacardiosoft.it/book)
  • Discloses the details of a marketed ECG Product (from GammaCardio Soft)  compliant with the ANSI standard AAMI EC 11under open licenses (GNU GPL, Creative Common)

This book is written for biomedical engineering courses(upper-level undergraduate and graduate students) and for engineersinterested in medical instrumentation/device design with acomprehensive and interdisciplinary system perspective.

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