Design Controls for The Medical Device Industry 1st Edition by Marie B Teixeira,Richard Bradley ISBN 082470830X 978-0824708306
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Product details:
ISBN 10: 082470830X
ISBN 13: 978-0824708306
Author: Marie B. Teixeira, Richard Bradley
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:
Chapter 1: Introduction
Chapter 2: Device Classification
Chapter 3: Overview of Design Controls
Chapter 4: Design and Development Planning
Chapter 5: Design Inputs—Part I
Chapter 6: Design Inputs—Part II
Chapter 7: Design Outputs
Chapter 8: Design Review
Chapter 9: Design Verification
Chapter 10: Risk Management
Chapter 11: Design Validation
Chapter 12: Biocompatibility
Chapter 13: Design Transfer
Chapter 14: Design Change
Chapter 15: Design History File
Chapter 16: The FDA Inspection Technique
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Tags: Marie B Teixeira, Richard Bradley, Design Controls, for The Medical, Device Industry