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 com.

Cover; Title Page; Copyright Page; Dedication; Contents; Acknowledgements; Chapter 1 -- Introduction; 1.1 -- Reminder concerning classification; 1.2 -- A reminder concerning the importance of design rigour (or design control); 1.3 -- A reminder concerning understanding the problem; 1.4 -- A reminder concerning a team/holistic approach; 1.5 -- A reminder concerning costs; 1.6 -- Introduction to the case studies; Case Study: The OTC Joint Support; Case Study: Surgical Wire Cutters; Case Study: Orthopaedic Cast; 1.6.1 -- Comments Concerning the Case Studies.

1.7 -- Hints to enable you to understand the textChapter 2 -- Classification; 2.1 -- Introduction; 2.1.1 -- Timing; 2.2 -- FDA classification; 2.2.1 -- Keywords; 2.3 -- EU MDD classification; 2.4 -- Your turn; Chapter 3 -- Taking the Design from Idea to PDS; 3.1 -- Introduction; 3.2 -- Developing the specification; 3.2.1 -- The Need; 3.2.2 -- The PDS; 3.2.3 -- Customer Section; 3.2.4 -- Regulatory and Statutory Section; 3.2.5 -- Technical Section and Performance Section; 3.2.6 -- Sales Section; 3.2.7 -- Manufacturing Section; 3.2.8 -- Packaging and Transportation Section; 3.2.9 -- Environmental Section.

Chapter 4 -- Conceptual …