Introduction to Medical Device Requirements Introduction The Challenges Sources of Errors Understanding the Science of Safety      Overview of FDA Quality System Regulation      Overview of Risk Management Standard ISO 14971      Overview of FDA Device Approval Process      Overview of Regulatory Requirements for Clinical Trials Summary References Preventing Recalls during Specification Writing Introduction Conduct Requirements Analysis to Identify Missing Requirements Specifications for Safety, Durability, and Reliability Specification for User Interface and Usability Specification for Maintainability Specification for Prognostics Specification for Safe Software Negative Requirements Analysis for Worst-Case Scenarios Conducting PHA to Assess Risks Considerations for In Vitro Devices Summary References Risk Assessment and Risk Management Introduction Developing Risk Acceptance Criteria Risk Analysis Using PHA Assessing the Risk Mitigating Risks Using World-Class Practices Risk Evaluation Managing Residual Risks Summary Reference Preventing Recalls during Early Design Introduction Functional FMEA on Design Concept to Prevent Failures Conducting a Component-Level FMEA to Identify Parameters Critical to Quality Conduct an FTA to Develop Robust Solutions for Complex Problems Strategy for Developing Solutions Summary References Preventing Recalls during the Detail Design Phase Introduction Designing for Durability Designing for Reliability Designing for Inherent Safety Designing for Inherent Quality Designing to Forgive User Errors Designing for Hazard-Free Maintenance Designing for Packaging Durability Testing Summary References Designing for Prognostics to Protect Patients Introduction Preventing False Positives and False Negatives Designing for Alerts When the Device Is Not Performing Accurately Designing to Alert When a Device Is Near the Low End of the Prognostic Distance Shutting Down the Device in a Safe State if the Failure Cannot Be Avoided Progress in Prognostics Health Monitoring Summary References Preventing Recalls during Production Validation Introduction Understanding Key Design Features That Result in Defect-Free Production Understanding the Theory of Profound Knowledge for Superior Quality Conducting HAZOP Analysis to Identify Latent Hazards in the Manufacturing Process Using ISO 14971 HACCP Analysis to Identify Critical Steps in a Process Assuring Conformance to Key Design Features without 100% Inspection or Testing Auditing to Identify Unacceptable Variation before Defects Are Produced Taking Corrective and Preventive Actions Using the FDA System Training Production Operators to Identify Incidents That May Result in Device Defects Production Validation Testing Summary References Preventing Software Design Recalls Introduction Software Requirements Analysis Software FMEA Software Interoperability Analysis Testability Analysis Selecting Software Structure and Architecture Precautions for Off-the-Shelf Software Designing to Minimize User Interface Risks      Common User Interface (UI) Issues      Common Reasons for Use Errors Summary References Preventing Supply Chain Quality Defects to Avoid Recalls Introduction Writing Good Supplier Specifications The Art of Identifying the Features Critical to Quality Assessing Variation in Supplier Quality Supply Chain Control by Suppliers Assuring Reliability in Performance Summary Reference Preventing Recalls Using a Verification Process Introduction Independent Verification during Specification Approval Independent Verification during Final Design Approval Independent Verification during Pilot Production Approval Independent Verification of Supplier Quality Assurance Verifying Day-to-Day Control in Production Summary Reference Preventing Recalls Using Design Validation Process Introduction Design Validation Testing for Reliability Design Validation Testing for Durability Design Validation for Safety Using Field Validation to Identify New Risks Summary Reference Recall Planning to Maximize Efficiency in the Event of a Recall Introduction Overview of the Plan Immediate Recall Coordination Review of the Discovered Risks Review of Data Management Verification of Activities for Effectiveness Closing the Recall Summary References Role of Management in Preventing Recalls Introduction Management Policies Management Tasks for Preventing Recalls Product Management Procedures Management Reviews Monitoring Risk Management Processes Using Good Paradigms for Efficiency Summary References Innovation Methods Useful in Preventing Recalls Introduction Stop Using Outdated Practices Use Heuristics Use the Profound Knowledge of the Quality and Safety Gurus Use Classic Innovation Methods Summary References Proactive Role of Marketing in Preventing Recalls Introduction Don''t Repeat Failures of Yesterday in Devices of Tomorrow Gather Intelligence on Customer Safety Needs during Lead Generation Gather Intelligence on Safety and Quality Issues on Device Search Engines Participate in Design Reviews to Be an Advocate for Users Review New Device Specifications with Trusted Customers Provide Intelligence in Risk Assessment to Ensure the Public Health Benefits Outweigh the Risk Market Safety Features to Promote the Device and to Get Feedback from Users Summary References Appendix A: Medical Device Safety from the Hospital''s Point of View Protecting Patients from Hidden Dangers in Medical Devices      What Are the Dangers?      How Can Hospitals Protect Patients from These Dangers?      Use a Team Approach to Risk Reduction References Appendix B: The FDA Quality System Regulation Code of Federal Regulations Title 21 (Food and Drugs), Part 820      Subpart A--General Provisions           Sec. 820.1 Scope           Sec. 820.3 Definitions           Sec. 820.5 Quality System Subpart B--Quality System Requirements           Sec. 820.

20 Management Responsibility           Sec. 820.22 Quality Audit           Sec. 820.25 Personnel Subpart C--Design Controls      Sec. 820.30 Design Controls Subpart D--Document Controls      Sec. 820.

40 Document Controls Subpart E--Purchasing Controls      Sec. 820.50 Purchasing Controls Subpart F--Identification and Traceability      Sec. 820.60 Identification      Sec. 820.65 Traceability Subpart G--Production and Process Controls      Sec. 820.

70 Production and Process Controls      Sec. 820.72 Inspection, Measuring, and Test Equipment      Sec. 820.75 Process Validation Subpart H--Acceptance Activities      Sec. 820.80 Receiving, In-Process, and Finished Device Acceptance      Sec. 820.

86 Acceptance Status Subpart I--Nonconforming Product      Sec. 820.90 Nonconforming Product Subpart J--Corrective and Preventive Action      Sec. 820.100 Corrective and Preventive Action Subpart K--Labeling and Packaging Control      Sec. 820.120 Device Labeling      Sec. 820.

130 Device Packaging Subpart L--Handling, Storage, Distribution, and Installation      Sec. 820.140 Handling      Sec. 820.150 Storage      Sec. 820.160 Distribution      Sec. 820.

170 Installation Subpart M--Records      Sec. 820.180 General Requirements      Sec. 820.181 Device Master Record      Sec. 820.184 Device History Record      Sec. 820.

186 Quality System Record      Sec. 820.198 Complaint Files Subpart N--Servicing      Sec. 820.200 Servicing Subpart O--Statistical Techniques      Sec. 820.250 Statistical Techniques Index.