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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
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