Class 1 Devices: Case Studies in Medical Devices Design

The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik’s Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library.

Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS.

These titles will assist anyone who is working in the medical devices industry or who is studying biomedical subject areas to design a successful medical device and avoid repeating past mistakes.Written by an experienced medical device engineer and entrepreneur, with real world experience of developing and commercializing medical products.Joins up theory and practice in an accessible style.

Introduction:

Chapter 1: Class I devices

Chapter 2: Class II devices

Chapter 3: Class III devices (high risk devices that are life threatening)

Chapter 4: In Vitro Diagnostic devices

Chapter 6: Active Implantable Devices

Chapter 7: Rehabilitation Devices