ABSTRACT

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical

chapter |2 pages

Section 1 Basics of reliability

chapter 1|12 pages

Reliability

chapter 2|8 pages

The concept of failure

chapter |2 pages

Section 2 Regulations and standards

chapter 3|28 pages

The Food and Drug Administration

chapter 4|24 pages

The Medical Devices Directives

chapter 5|18 pages

Quality system regulation

chapter 6|6 pages

Domestic standards

chapter 7|12 pages

International standards

chapter |2 pages

Section 3 Specifying the product

chapter 8|6 pages

The medical device as an entity

chapter 9|18 pages

Defining the device

chapter 10|18 pages

10

chapter 11|20 pages

11

chapter 12|10 pages

Liability

chapter 13|20 pages

13

chapter |2 pages

Section 4 Designing the product

chapter 14|22 pages

Six Sigma and product design

chapter 15|24 pages

Hardware design

chapter 16|20 pages

Software design

chapter 17|10 pages

Software coding

chapter 18|14 pages

Establishing and using metrics

chapter 19|32 pages

Human factors

chapter |2 pages

Section 5 Testing and data analysis

chapter 20|16 pages

The basis and types of testing

chapter 21|22 pages

Hardware verification and validation

chapter 22|12 pages

Software verification and validation

chapter 23|12 pages

Analysis of test results

chapter 24|12 pages

GMPs and manufacturing

chapter 25|8 pages

Configuration management

chapter 26|6 pages

Analysis of field data