Enhanced descriptions from Syndetics:

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 provided by Syndetics

• Preface (p. iii)
• 1 Overview (p. 1)
• An Idea Is Born (p. 1)
• Ask the Customer (p. 2)
• Design Controls and the FDA (p. 3)
• Design Controls and Reality (p. 4)
• Design Controls and the Bottom Line (p. 5)
• Design Controls and the Customer (p. 7)
• 2 Design and Development Planning (p. 11)
• Do We Really Need a Plan? (p. 11)
• What's a Plan? (p. 13)
• The FDA, Design Controls, and Plans (p. 14)
• Planning Techniques (p. 16)
• Are Projects Really Always Late and Overbudget? (p. 19)
• 3 Design Input I (p. 25)
• Input, Who Needs Input? (p. 25)
• The Foundation--Design Input (p. 27)
• The FDA and Design Input (p. 27)
• The Importance of Design Input and FDA Requirements (p. 28)
• The Concept Document (p. 29)
• Product Performance Specification (p. 31)
• 4 Design Input II (p. 35)
• To Design Control or Not to Design Control (p. 35)
• Performance Characteristics (p. 36)
• Product Characteristics (p. 42)
• Market Requirements (p. 46)
• Regulatory and Quality Assurance and Contractual Requirements (p. 47)
• 5 Design Outputs (p. 49)
• If Design Controls Are Cyclic, Why Didn't We Just Cover Outputs? (p. 49)
• The FDA and Design Outputs (p. 50)
• There Must Be an End (p. 51)
• Design Output Requirements (p. 53)
• The Device Master Record (p. 55)
• 6 Design Review (p. 59)
• Not Another Meeting! (p. 59)
• The FDA and Design Reviews (p. 60)
• Design Review Requirements (p. 61)
• Design Review Focus (p. 62)
• Design Review Stages (p. 63)
• Meeting Dynamics (p. 66)
• 7 Design Verification (p. 77)
• What Is Design Verification? (p. 77)
• The FDA and Design Verification (p. 78)
• Design Verification Requirements (p. 78)
• Typical Verification Activities (p. 79)
• Risk Management (p. 80)
• Human Factors (p. 85)
• Risk Management Documentation (p. 86)
• 8 Design Validation (p. 89)
• Why Validate? (p. 89)
• The FDA and Validation (p. 90)
• Design Validation Requirements (p. 90)
• Typical Validation Activities (p. 92)
• Risk Analysis ... One More Time (p. 92)
• Common Risk Analysis Tools (p. 93)
• Risk Assessment of Medical Device Materials (p. 99)
• Biocompatibility (p. 102)
• Regulatory Aspects of Biocompatibility (p. 104)
• Phases of Biocompatibility Testing (p. 107)
• Tests to Demonstrate Biocompatibility (p. 111)
• 9 Process Validation (p. 123)
• It's No Good If You Can't Make It (p. 123)
• The FDA and Process Validation (p. 124)
• What Do You Call a Group of Processes? (p. 125)
• Statistical Process Control (p. 130)
• 10 Design Transfer (p. 137)
• What Is Design Transfer? (p. 137)
• Check Your Attitude at the Door (p. 138)
• The FDA and Design Transfer (p. 140)
• Design Transfer Requirements (p. 141)
• 11 Design Changes (p. 143)
• The Purpose of Design Change Control (p. 143)
• The FDA and Design Changes (p. 144)
• Design Change Requirements (p. 144)
• The Document Change Request (p. 146)
• 12 The Design History File (p. 147)
• Why Do We Need a Design History File? (p. 147)
• The FDA and the Design History File (p. 148)
• Design History File Requirements (p. 148)
• 13 Questions to Expect in an Audit (p. 151)
• An Audit! Now What? (p. 151)
• The FDA Design Controls Inspection Objectives (p. 151)
• Some Questions You May Be Asked (p. 153)
• Further Reading (p. 157)
• Appendix A Implementation Procedure (p. 161)
• Appendix B Concept Document (p. 175)
• Appendix C Product Specification (p. 179)
• Appendix D Product Claims Sheet (p. 191)
• Appendix E Risk Analysis: Standard Operating Procedure (p. 193)
• Appendix F Cause-and-Effects Diagram (p. 205)
• Appendix G Validation Procedure (p. 209)
• Appendix H Material Specification (p. 221)
• Appendix I Quality Specification (p. 225)
• Appendix J Design Change Procedure (p. 227)
• Index (p. 239)

Author notes provided by Syndetics