Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies

chapter 1|6 pages

Introduction to Quality Systems

chapter 2|14 pages

Validation Overview

chapter 3|20 pages

Product Development and Validation

chapter 5|18 pages

Process Development and Validation

chapter 6|18 pages

Test Method Development and Validation

chapter 9|14 pages

Facility Qualification Studies

chapter 12|6 pages

Revalidation and Requalification Studies