FDA, Good Manufacturing Practices GMP, quality system, QSR, ISO 13485, regulatory consultants, manufacturing development device, drug, diagnostic, combination medical products, 510k, PMA, IDE
book, design control, input verification, validation, review, development, clinical trial, plans, history file, DHF, ISO 13485, PMA, 510k, IDE, example documents Meeting GMP and ISO 9001 Expectations for Product Development

by Charmaine Vercimak Sutton and Carol DeSain
Parexel International Corporation - 1996

This book was written to help medical device and diagnostic manufacturers comply with the Quality System Design Control regulations of 21 CFR 820.30. Specifically this text will help you define your product development process and develop quality systems for the product development department. Just as importantly, the guidance in this text will help medical product developers institute design controls that meet GMP and ISO expectations without stifling product development.

Table of Contents
Chapter 1: Introduction
Chapter 2: Quality Systems in Product Development
Chapter 3: Developing a Product Development Master Plan
Chapter 4: Standard Practices in Product Development
Chapter 5: Product Requirements Development
Chapter 6: Component and Final Product Specifications
Chapter 7: Process Development
Chapter 8: Test Method Development
Chapter 9: Documentation Practices for Product Development
Chapter 10: Maintenance and Monitoring Programs for Product Development
Chapter 11: Change Management for Product Development
Chapter 12: Managing Unexpected Events in Product Development
Chapter 13: The Investigative Process

Soft cover book - $145.00: To Order

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