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Title: Design Controls for the Medical Device Industry
Design Controls for the Medical Device Industry
By: Marie B. Teixeira and Richard Bradley
ISBN: 978 0824 70830 6
Publisher: Marcel Dekker
Copyright: 2003
Page Count: 250
Trim Size: 6 x 9
Format: Hardcover
Catalog #: 03248
Status: Normally in stock
List Price: $169.95
Our Price: $151.50
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Keywords associated with this title: Medical Devices
Quality Management

 

This reference provides strategies and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations — offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Detailing procedures utilized by leading companies to meet FDA and end-user requirements, manufacture of high quality products, and improve and generate profit, Design Controls for the Medical Device Industry contains valuable guidelines to prepare for an FDA audit; identify customer needs, resolve project objectives, process inconsistencies and discrepancies; determine the compatibility of design specifications with manufacturing, installation, and servicing demands; and much more.

 

From the Preface: “...Throughout this book, we approach design control as a mandated regulation for the medical device industry in the United States. Companies that develop and manufacture class III, class II, and certain class I devices must have a design control program in place. But there is another, and in some ways more important definition of design control. Simply stated, it is a process that allows a company to make a high-quality product, from inception through production, and be reasonably sure that the resources spent in the development will result in a product that works, is useful, and is what the customer needs...”

 

Target Audience: Biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level student in these disciplines.

 

Table of Contents:

 

Overview

Design and Development Planning

Design Input I

Design Input II

Design Outputs

Design Review

Design Verification

Design Validation

Process Validation

Design Transfer

Design Changes

The Design History File

Questions to Expect in an Audit

Appendices: Implementation Procedure, Concept Document, Product Specification, Product Claims Sheet, Risk Analysis — Standard Operating Procedure, Cause-and-Effects Diagram, Validation Procedure, Material Specification, Quality Specification, Design Change Procedure

Index

 

Primary Topic: QA/QC, Statistics, and Testing
Related Topics: Biopolymers and Medical Applications
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