Chapter 1



This chapter introduces the book and provides information on the individual case studies.


design rigour
class I
510(k) exempt
wire cutter
orthopaedic braces
over the counter items
This book complements the original text in Medical Devices Design: Innovation from Concept to Market1 (from now on I am going to call this the reference text). The intention of this book, and its sister books in the series, is to support the concepts presented in the reference text through case studies. In the context of this book, the case studies consider Class I (EU) and 510(k) exempt (FDA).2

1.1. Reminder concerning classification

Before we go any further with our discussions, we should remind ourselves about ...

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