Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, desig

part |2 pages


part |2 pages

PART TWO Medical Device Reliability

chapter 6|8 pages

Medical Device Reliability Overview

chapter 7|10 pages

Reliability Plan

chapter 8|22 pages

Risk Analysis and FMEA

chapter 9|20 pages

Designing-in Reliability

chapter 10|16 pages

Reliability and Design Verification

chapter 11|4 pages

Reliability and Design Validation