Description

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.
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 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.

Overview
Design and Development Planning
Design Input 1
Design Input 2
Design Outputs
Design Review
Design Verification
Design Validation
Process Validation
Design Transfer
Design Changes
The Design History File
Questions to Expect in an Audit
Further Reading
Appendix A: Implementation Procedure
Appendix B: Concept Document
Appendix C: Product Specification
Appendix D: Product Claims Sheet
Appendix E: Risk Analysis: Standard Operating Procedure
Appendix F: Cause-and-Effects Diagram
Appendix G: Validation Procedure
Appendix H: Material Specification
Appendix I: Quality Specification
Appendix J: Design Change Procedure
Index