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Design controls for the medical device industry [electronic resource] /
Marie B. Teixeira, Richard Bradley.
New York : Marcel Dekker, c2003.
x, 242 p. : ill. ; 23 cm.
082470830X (alk. paper), 9780824708306 (alk. paper)
More Details
New York : Marcel Dekker, c2003.
082470830X (alk. paper)
9780824708306 (alk. paper)
Licensed for access by U. of T. users.
catalogue key
Includes bibliographical references (p. 157-159) and index.
A Look Inside
About the Author
Author Affiliation
Marie B. Teixeira is President, QA/RA Compliance Connection, Inc., Odessa, Florida Richard Bradley is Managing Partner, The Global Consulting Network, Inc., Palm Harbor, Florida
This item was reviewed in:
SciTech Book News, December 2002
To find out how to look for other reviews, please see our guides to finding book reviews in the Sciences or Social Sciences and Humanities.
Back Cover Copy
This reference provides real-world examples, 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. Details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to prepare for an FDA audit identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies determine the compatibility of design specifications and manufacturing, installation, and servicing demands ensure that proper design, function, and performance stipulations are understood and met verify and validate design criteria and production schemes eliminate confusion and prevent communication breakdowns allocate and conserve resources perform risk assessment analyses predict potential hazards under normal and fault conditions Presenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines.
Table of Contents
Prefacep. iii
Overviewp. 1
An Idea Is Bornp. 1
Ask the Customerp. 2
Design Controls and the FDAp. 3
Design Controls and Realityp. 4
Design Controls and the Bottom Linep. 5
Design Controls and the Customerp. 7
Design and Development Planningp. 11
Do We Really Need a Plan?p. 11
What's a Plan?p. 13
The FDA, Design Controls, and Plansp. 14
Planning Techniquesp. 16
Are Projects Really Always Late and Overbudget?p. 19
Design Input Ip. 25
Input, Who Needs Input?p. 25
The Foundation--Design Inputp. 27
The FDA and Design Inputp. 27
The Importance of Design Input and FDA Requirementsp. 28
The Concept Documentp. 29
Product Performance Specificationp. 31
Design Input IIp. 35
To Design Control or Not to Design Controlp. 35
Performance Characteristicsp. 36
Product Characteristicsp. 42
Market Requirementsp. 46
Regulatory and Quality Assurance and Contractual Requirementsp. 47
Design Outputsp. 49
If Design Controls Are Cyclic, Why Didn't We Just Cover Outputs?p. 49
The FDA and Design Outputsp. 50
There Must Be an Endp. 51
Design Output Requirementsp. 53
The Device Master Recordp. 55
Design Reviewp. 59
Not Another Meeting!p. 59
The FDA and Design Reviewsp. 60
Design Review Requirementsp. 61
Design Review Focusp. 62
Design Review Stagesp. 63
Meeting Dynamicsp. 66
Design Verificationp. 77
What Is Design Verification?p. 77
The FDA and Design Verificationp. 78
Design Verification Requirementsp. 78
Typical Verification Activitiesp. 79
Risk Managementp. 80
Human Factorsp. 85
Risk Management Documentationp. 86
Design Validationp. 89
Why Validate?p. 89
The FDA and Validationp. 90
Design Validation Requirementsp. 90
Typical Validation Activitiesp. 92
Risk Analysis ... One More Timep. 92
Common Risk Analysis Toolsp. 93
Risk Assessment of Medical Device Materialsp. 99
Biocompatibilityp. 102
Regulatory Aspects of Biocompatibilityp. 104
Phases of Biocompatibility Testingp. 107
Tests to Demonstrate Biocompatibilityp. 111
Process Validationp. 123
It's No Good If You Can't Make Itp. 123
The FDA and Process Validationp. 124
What Do You Call a Group of Processes?p. 125
Statistical Process Controlp. 130
Design Transferp. 137
What Is Design Transfer?p. 137
Check Your Attitude at the Doorp. 138
The FDA and Design Transferp. 140
Design Transfer Requirementsp. 141
Design Changesp. 143
The Purpose of Design Change Controlp. 143
The FDA and Design Changesp. 144
Design Change Requirementsp. 144
The Document Change Requestp. 146
The Design History Filep. 147
Why Do We Need a Design History File?p. 147
The FDA and the Design History Filep. 148
Design History File Requirementsp. 148
Questions to Expect in an Auditp. 151
An Audit! Now What?p. 151
The FDA Design Controls Inspection Objectivesp. 151
Some Questions You May Be Askedp. 153
Further Readingp. 157
Implementation Procedurep. 161
Concept Documentp. 175
Product Specificationp. 179
Product Claims Sheetp. 191
Risk Analysis: Standard Operating Procedurep. 193
Cause-and-Effects Diagramp. 205
Validation Procedurep. 209
Material Specificationp. 221
Quality Specificationp. 225
Design Change Procedurep. 227
Indexp. 239
Table of Contents provided by Syndetics. All Rights Reserved.

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