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Medical Product Software Development and FDA Regulations

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  • 1. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance IEEE Orange County Computer Society March 27, 2006 Carl R. Wyrwa
  • 2. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA Regulations Introduction Regulated Software FDA Overview Medical Device Definition Software – Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion 2
  • 3. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance The Intent Of Regulating Software Medical Device Safety and Efficacy Patients Environment Operators Bystanders Service Personnel 3
  • 4. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Many Stakeholders – Keeping A Total Solution In Mind Safety Patients Operators Bystanders Service People Environment Customer Medical and Practitioners Business Needs All Needs Met Quality Reviewers Systems Internal Auditors and External Reviewers Q&RA People Doing The Work 4
  • 5. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Many Stakeholders – Keeping A Balanced Solution In Mind Safety Patients Operators Bystanders Service People Customer Environment Medical and Practitioners Business Needs All Needs Met Quality Systems Reviewers and Internal Auditors Q&RA External Reviewers People Doing The Work 5
  • 6. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA Regulations Introduction Regulated Software FDA Overview Medical Device Definition Software – Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion 6
  • 7. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Types of Regulated Software Medical Device Software Software that is actually a part of the medical device itself Software that is an accessory to a medical device Software that itself is a medical device 7
  • 8. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Types of Regulated Software Medical Device Software Non-Device Software that is part of: Software that is actually a part The production system of the medical device itself The quality system Software that is an accessory Systems that are used to create to a medical device and maintain records required Software that itself is a medical by FDA regulations device 8
  • 9. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA Regulations Introduction Regulated Software FDA Overview Medical Device Definition Software – Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion 9
  • 10. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance FDA Overview FDA is a public health agency, charged with: protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act and several related public health laws. It is FDA's job to see that: the food we eat is safe and wholesome, the cosmetics we use won't hurt us, the medicines and medical devices we use are safe and effective, and that radiation-emitting products, such as microwave ovens, won't do us harm One of our nation's oldest consumer protection agencies. Located in district and local offices in 157 cities across the country 10
  • 11. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Devices 32,358 11
  • 12. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance FDA Overview Administrative Enforcement Powers Unannounced and Announced Inspections Inspectional Observations - 483 Warning Letters Adverse Publicity FDA-Initiated Recalls and Monitoring Company-Initiated Recalls Delay, Suspension, or Withdrawal of Product Approvals Preclusion of Government contracts Detention and Refusal of Entry into U.S. Commerce of Imported Products Judicial Enforcement Powers Civil Enforcement Powers (Seizure) Criminal Enforcement Powers (Prosecution) 12
  • 13. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA Regulations Introduction Regulated Software FDA Overview Medical Device Definition Software – Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion 13
  • 14. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Device Definition Medical devices range from Simple Devices Tongue depressors and bedpans Complex Devices Programmable pacemakers Laser surgical devices Medical Device Classification – Class I, II, and III Class I devices include those with the lowest risk Class III devices includes those with the greatest risk. 14
  • 15. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Device Definition • "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, • and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes." 15
  • 16. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA Regulations Introduction Regulated Software FDA Overview Medical Device Definition Software – Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion 16
  • 17. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance 820.30 Design Control 820.30(a) General (1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall: establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. (2) The following class I devices are subject to design controls: (i) Devices automated with computer software; and (ii) The devices listed ….. Below: Catheter, Tracheobronchial Suction Glove, Surgeon’s Restraint, Protective System, Applicator, Radionuclide, Manual Source, Radionuclide Teletherapy 17
  • 18. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software – Special Attention General Principles of Software Validation 3.3 Software Is Different From Hardware “Because of its complexity, the development process for software should be even more tightly controlled than for hardware, in order to prevent problems that cannot be easily detected later in the development process”. “……. software engineering needs an even greater level of managerial scrutiny and control than does hardware engineering”. [1] 18
  • 19. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA Regulations Introduction Regulated Software FDA Overview Medical Device Definition Software – Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion 19
  • 20. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Regulation of Software Design Controls Basic Regulatory Quality System Regulation Requirements 820.30(a) A - General Provisions General B - Quality System 21 CFR 807 Requirements 820.30(b) Design & Development Planning Establishment Registration C – Design Controls 820.30(c) D – Document Controls Design Input 21 CFR 807 Medical Device Listing E – Purchasing Controls 820.30(d) F – Identification Design Output 21 CFR 807 and Traceability G – Production & Process 820.30(e) Premarket Notification 510(k) Controls Design Review H – Acceptance Activities 21 CFR 814 820.30(f) Design Verification Premarket Approval PMA I – Nonconforming Product J – Corrective & Preventive 820.30(g) 21 CFR 820 Action (CAPA) Design Validation K – Labeling & Packaging Quality System Regulation Control 820.30(h) L – Handling, Storage, Design Transfer 21 CFR 801 Distribution & Installation 820.30(i) Labeling M - Records Design Changes N - Servicing 820.30 (j) 21 CFR 803 Design History File20 Medical Device Reporting O – Statistical Techniques
  • 21. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Regulation of Software Production & Process Controls Basic Regulatory Quality System Regulation Requirements 820.70(a) A - General Provisions General B - Quality System 21 CFR 807 Requirements 820.70(b) Production & Process Changes Establishment Registration C – Design Controls 820.70(c) D – Document Controls 21 CFR 807 Environmental Control Medical Device Listing E – Purchasing Controls 820.70(d) F – Identification Personnel 21 CFR 807 and Traceability G – Production & Process 820.70(e) Premarket Notification 510(k) Controls Contamination Control H – Acceptance Activities 21 CFR 814 820.70(f) Buildings Premarket Approval PMA I – Nonconforming Product J – Corrective & Preventive 820.70(g) 21 CFR 820 Action (CAPA) Equipment K – Labeling & Packaging Quality System Regulation Control 820.70(h) L – Handling, Storage, Manufacturing Material 21 CFR 801 Distribution & Installation 820.70(i) Labeling M - Records Automated Processes N - Servicing 21 CFR 803 21 Medical Device Reporting O – Statistical Techniques
  • 22. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Regulation of Software Basic Regulatory Quality System Regulation Requirements A - General Provisions B - Quality System 21 CFR 807 Requirements Establishment Registration C – Design Controls D – Document Controls 21 CFR 807 Medical Device Listing E – Purchasing Controls F – Identification 21 CFR 807 and Traceability G – Production & Process Premarket Notification 510(k) Controls H – Acceptance Activities Quality System 21 CFR 814 Requirements Premarket Approval PMA I – Nonconforming Product J – Corrective & Preventive 820.100 21 CFR 820 Action (CAPA) Action (CAPA) Corrective & Preventive Action K – Labeling & Packaging Quality System Regulation Control L – Handling, Storage, 21 CFR 801 Distribution & Installation Labeling M - Records N - Servicing 21 CFR 803 22 Medical Device Reporting O – Statistical Techniques
  • 23. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Regulation of Software Basic Regulatory Quality System Regulation Quality System Requirements Requirements A - General Provisions 820.25(a) B - Quality System General 21 CFR 807 Requirements 820.25(b) Establishment Registration C – Design Controls Training D – Document Controls 21 CFR 807 820.22 Quality Audit Medical Device Listing E – Purchasing Controls F – Identification 21 CFR 807 and Traceability G – Production & Process Premarket Notification 510(k) Controls H – Acceptance Activities 21 CFR 814 Premarket Approval PMA I – Nonconforming Product J – Corrective & Preventive 21 CFR 820 Action (CAPA) K – Labeling & Packaging Quality System Regulation Control L – Handling, Storage, 21 CFR 801 Distribution & Installation Labeling M - Records N - Servicing 21 CFR 803 23 Medical Device Reporting O – Statistical Techniques
  • 24. Procedures Medical Product Software Development and FDA Regulations Plans Software Development Practices and FDA Compliance SW Life-Cycle Model SW Requirements Analysis SW Requirements Verification Software Basic Requirements SW Architectural Design SW Architecture Verification SW Detailed Design Quality System Regulation SW Detailed Design Verification A - General Provisions SW Coding B - Quality System SW Code Verification Requirements Unit Test C – Design Controls Integration Test D – Document Controls SW System Test Beta Testing E – Purchasing Controls SW Verification F – Identification and Traceability SW Validation G – Production & Process COTS Software Components Controls SW Risk/Hazard Analysis H – Acceptance Activities SW Human Factors (Use Errors) I – Nonconforming Product SW Change Control J – Corrective & Preventive SW Configuration Management Action (CAPA) K – Labeling & Packaging SW Problem Tracking & Resolution Control SW Traceability L – Handling, Storage, Distribution & Installation Non-Product Software Validation M - Records Corrective & Preventive Action (CAPA) Design Transfer N - Servicing Design History File 24 O – Statistical Techniques Training Software Quality Audits
  • 25. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA Regulations Introduction Regulated Software FDA Overview Medical Device Definition Software – Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion 25
  • 26. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Procedures and Plans Procedures Plans You must be able to demonstrate that you are “Operating In A State Of Control” Procedures + Plans • Establish, in advance of activities, what you are going to do. • Do what you say you are going to do. 26 • Be able to provide objective (documented) evidence.
  • 27. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Development SW Life-Cycle Model SW Requirements Analysis SW Requirements Verification SW Architectural Design SW Architecture Verification SW Detailed Design SW Detailed Design Verification SW Coding SW Code Verification 27
  • 28. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Testing Unit Test Integration Test SW System Test Beta Testing 28
  • 29. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Verification & Validation SW Verification “Engineering Correctness Checks” SW Validation “Intended Use Confirmation” 29
  • 30. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Supporting Processes COTS Software Components SW Risk/Hazard Analysis SW Human Factors (Use Errors) SW Change Control SW Configuration Management SW Problem Tracking & Resolution SW Traceability Non-Product Software Validation Corrective and Preventive Action (CAPA) 30
  • 31. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Release Design Transfer Design History File 31
  • 32. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Personnel Training Software Quality Audits 32
  • 33. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA Regulations Introduction Regulated Software FDA Overview Medical Device Definition Software – Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion 33
  • 34. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Quality and Software Safety The Reason WHY we need to have a comprehensive and effective Software Development Life Cycle 34
  • 35. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance The Intent Of Regulating Software Medical Device Safety and Efficacy Patients Environment Operators Bystanders Service Personnel 35
  • 36. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Understanding Defects Defects [2] Start Development Process Ship 36
  • 37. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Understanding Defects Defects Defects Injected [2] Start Development Process Ship 37
  • 38. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Understanding Defects Defects Defects } Defects Shipped Injected Defects Detected And Corrected [2] Start Development Process Ship 38
  • 39. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance A Journey To Fewer Defects Overall Software Quality Inject Fewer Defects [2] Start Development Process Ship 39
  • 40. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Quality Model Understanding Defect Injection Rates Software Software Software Software High-Level Detailed Requirements Coding Design Design Defect injection rates can be reduced by Performing these activities highly effectively and introducing Causal Analysis 40
  • 41. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Quality Model Understanding Defect Injection Rates Software Software Software Software High-Level Detailed Requirements Coding Design Design Defect injection rates will increase if You do not perform these activities well or you decide not to do the activity at all 41
  • 42. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Quality Model Understanding Defect Injection Rates Software Software Software Software High-Level Detailed Requirements Coding Design Design Defect Injection Rates are directly related to the completeness and the effectiveness of each of these activities 42
  • 43. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Quality Model Understanding Defect Injection Rates 100 90 80 Defects Cumulative Defects 70 Injected 60 50 40 30 20 10 0 s qs n n g st st t d st er eq Re sig sig din Te Te es al i Te m ys R De De Co it In t sT sV ta sto S SW HL t Un Sy Sy Be Cu De SW Defects per 1000 lines of code 43
  • 44. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance A Journey To Fewer Defects Overall Software Quality Inject Fewer Defects Detect More Effectively Detect Earlier [2] Start Development Process Ship 44
  • 45. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Quality Model Increasing Effectiveness Software Software Software Software High-Level Detailed Requirements Coding Design Design Verification Verification Verification Verification Software Unit Integration System Beta Site System Customer Test Test Validation Testing 45 Test
  • 46. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance A Journey To Fewer Defects Overall Software Quality Inject Fewer Defects Fewer } Defects Detect More Zero? Effectively Detect Earlier [2] Start Development Process Ship 46
  • 47. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA Regulations Introduction Regulated Software FDA Overview Medical Device Definition Software – Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion 47
  • 48. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Safety Model Risk/Hazard Analysis & Use Error Analysis Risk/Hazard Analysis Use Error Analysis Software Harm To: Software Software Software High-Level Detailed Requirements Patients Design Design Coding Operators Verification Bystanders Verification Verification Verification Service Personnel Environment Software Unit Integration System Beta Site System Customer Test Test Validation Testing 48 Test
  • 49. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Safety Model Risk/Hazard Analysis & Use Error Analysis Risk/Hazard Analysis Use Error Analysis Software Induced By: Software Software Software High-Level Detailed Requirements Basic Functionality Design Design Coding Software Defects Verification Use Errors Verification Verification Verification Environment Interfaces Software Unit Integration System Beta Site System Customer Test Test Validation Testing 49 Test
  • 50. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Safety Model Risk/Hazard Analysis & Use Error Analysis Software Software Software Software High-Level Detailed Requirements Coding Design Design Verification Verification Verification Verification Software Unit Integration System Beta Site System Customer Test Test Validation Testing 50 Test
  • 51. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Safety Model Risk/Hazard Analysis & Use Error Analysis Risk/Hazard Analysis Use Error Analysis Software Software Software Software High-Level Detailed Requirements Coding Design Design Verification Verification Verification Verification Software Unit Integration System Beta Site System Customer Test Test Validation Testing 51 Test
  • 52. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Safety Model A Continuous Process Throughout the Life Cycle Risk/Hazard Analysis Use Error Analysis Software Software Software Software High-Level Detailed Requirements Coding Design Design Verification Verification Verification Verification Software Unit Integration System Beta Site System Customer Test Test Validation Testing 52 Test
  • 53. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Safety Model A Continuous Process Throughout the Life Cycle Risk/Hazard Analysis Use Error Analysis Software Software Software Software High-Level Detailed Requirements Coding Design Design Verification Verification Verification Verification Software Unit Integration System Beta Site System Customer Test Test Validation Testing 53 Test
  • 54. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Safety Model A Continuous Process Throughout the Life Cycle Risk/Hazard Analysis Use Error Analysis Software Software Software Software High-Level Detailed Requirements Coding Design Design Verification Verification Verification Verification Software Unit Integration System Beta Site System Customer Test Test Validation Testing 54 Test
  • 55. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Safety Model Use Error Analysis User Error X User Error – Blames The User For Doing Something Wrong Use Error – Developer takes accountability for developing software that allowed the user to make an error And…..the developer incorporates Use Error Analysis into the risk management process resulting in the implementation of built-in safeguards to protect against Use Error 55
  • 56. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Safety Model Use Error Analysis Use Error (Human Factors) Considerations Skill Level Variation Environmental Variation Compromising Factors Physical and Sensory Characteristics Perception Cognition Expectancies Mental Models Home Use 56
  • 57. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Safety Model Risk/Hazard Analysis & Use Error Analysis Potential Harm Potential Harm Potential Harm Potential Harm Potential Harm To To To To To Patients Operators Bystanders Service Environment Personnel Basic You are developing a Functionality function where the user will be asked to Defects manually enter a patient’s age Use Errors YES You realize that if the Environment age is entered incorrectly that an incorrect diagnosis might be made Interfaces 57
  • 58. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Safety Model Risk/Hazard Analysis & Use Error Analysis Post Function Potential Potential Control Severity Control V&V Feature Event Hazard Mitigation Severity Patient Enter Test Incorrect Age Incorrect Age Major Date of Birth Acceptable Procedure 58 Entered Diagnosis Entry (Use Error) (cross check) 12345
  • 59. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Safety Model Risk/Hazard Analysis & Use Error Analysis 59
  • 60. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA Regulations Introduction Regulated Software FDA Overview Medical Device Definition Software – Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion 60
  • 61. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Recall Statistics Software Related Recalls Initial (21%) Due To Changes (79%) FDA Analysis – 3140 Recalls (1992 – 1998) Software-related recalls – 242 Software recalls due to changes – 192 (79%) “Of those software related recalls, 192 (or 79%) were caused by software defects that were introduced when changes were made to the software after its initial production and distribution” 61 FDA Guidance (2002) General Principles of Software Validation
  • 62. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Maintenance Challenges Oversimplification of the task Customer and Patient expectations Increased requirements on system Changes Design additions and/or modifications State of the documentation Knowledge level Personnel changes Software components (COTS) Hardware components Interfaces Cybersecurity issues Maintenance Challenges 62
  • 63. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Creating A Balance Processes Challenges Requirements management Oversimplification of the task Anomaly management Customer and Patient expectations Technology transition management Increased requirements on system Changes Risk management Design additions and/or modifications Training State of the documentation Change control Knowledge level Software development life cycle Personnel changes Technical reviews Software components (COTS) Validation planning Hardware components Testing Interfaces Configuration management Cybersecurity issues Documentation updates 63
  • 64. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA Regulations Introduction Regulated Software FDA Overview Medical Device Definition Software – Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion 64
  • 65. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Corrective Action – Preventive Action (CAPA) Process Change Prevent Similar Problems From Other Products Occurring In Similar Problems? The Future Investigate Same Product Find Root Cause Similar Problems? Correct The Problem Investigate Find Root Cause Problem Encountered Correct The Problem Investigate Find Root Cause Correct The Problem 65
  • 66. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA Regulations Introduction Regulated Software FDA Overview Medical Device Definition Software – Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion 66
  • 67. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Quality System The Regulation Regulation • The Quality System Regulation 21 CFR 820 Medical Device Quality Design Control Guidance FDA General References System Manual • Medical Device Quality System Manual Medical Device • Design Control Guidance Do It By Design Use Safety Human Factors • Do It By Design Risk Mgmnt • Medical Device Use Safety (Human Factors/Use Errors) • Guide To Inspections Of Quality Systems (QSIT) Guide To Inspections Of Quality Systems (QSIT) General Principles of Software Pre-Market Off-The-Shelf Software FDA Software Specific References Software Validation Submission Guidance Guidance • General Principles of Software Validation • Software Pre-market Submission Guidance • Off-The-Shelf Software Guidance ANSI/AAMI ISO ISO Industry References SW68:2001 Software ISO 62304 13485 14971 • ANSI/AAMI SW68 • ISO 13485 67 Processes • ISO 62304 • ISO 14971
  • 68. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance General Principles of Software Pre-Market Off-The-Shelf Software FDA Software Specific References Software Validation Submission Guidance Guidance • General Principles of Software Validation • Software Pre-market Submission Guidance • Off-The-Shelf Software Guidance ANSI/AAMI Industry References SW68:2001 ISO Software 62304 • ANSI/AAMI SW68 Processes • ISO 62304 68
  • 69. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance FDA Software-Specific Guidance Documents 69
  • 70. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance FDA Software-Specific Guidance Documents 70
  • 71. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance ANSI/AAMI SW68:2001 Medical Device Software - Software life cycle processes 71
  • 72. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance AAMI TIR32:2004 Medical device software risk management 72
  • 73. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance FDA Website www.fda.gov Click On “Medical Devices” 73
  • 74. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance FDA Website CDRH A-Z Index Click On “CDRH A-Z Index” 74
  • 75. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance FDA Website Click On “S” For Software 75
  • 76. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance FDA Website Scroll Down To “Software” 76
  • 77. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance FDA Website 77
  • 78. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance FDA Website http://www.fda.gov/cdrh/humanfactors/ 78
  • 79. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance AAMI Website www.aami.org 79
  • 80. Procedures Medical Product Software Development and FDA Regulations Plans Software Development Practices and FDA Compliance SW Life-Cycle Model SW Requirements Analysis SW Requirements Verification SW Architectural Design SW Architecture Verification SW Detailed Design Medical Device General SW Detailed Design Verification Design Control Principles of Quality SW Coding Guidance Software System Manual Validation SW Code Verification Unit Test Medical Device Software Do It By Use Safety Pre-Market Integration Test Design Human Factors Submission ANSI/AAMI Risk Mgmnt Guidance SW68:2001 SW System Test Software Quality System Beta Testing Processes Regulation Guide To Off-The-Shelf SW Verification Inspections Of Software Quality Systems Guidance SW Validation (QSIT) COTS Software Components SW Risk/Hazard Analysis SW Human Factors (Use Errors) SW Change Control SW Configuration Management SW Problem Tracking & Resolution SW Traceability Non-Product Software Validation Corrective & Preventive Action (CAPA) Design Transfer Design History File 80 Training Software Quality Audits
  • 81. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Medical Product Software Development and FDA Regulations Introduction Regulated Software FDA Overview Medical Device Definition Software – Special Attention Regulation Of Software Basic Requirements Software Quality Model Software Safety Model Software Maintenance Corrective Action and Preventive Action (CAPA) Reference Material Conclusion 81
  • 82. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Software Quality Model Risk/Hazard Analysis Use Error Analysis CAPA Low Defect Injection Rates Software Software Software Software High-Level Detailed Requirements Coding Design Design Verification Verification Verification Verification Early and Highly Effective Defect Detection Steps Software Unit Integration System Beta Site System Customer Test Test Validation Testing 82 Test
  • 83. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance It’s All About Making It Safe Your Families! - Your Loved Ones! - Your Friends! Each and Every One Of YOU! Patients Environment Operators Bystanders Service Personnel 83
  • 84. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance Carl R. Wyrwa UC Irvine Extension Program MedicalDeviceSW@aol.com Medical Product Development Medical Device Engineering MedicalDeviceSoftware.com BME X401 Software-Controlled Medical Devices Software Engineering & Compliance http://unex.uci.edu/certificates/life_sciences/medical_products/details.asp 84
  • 85. Medical Product Software Development and FDA Regulations Software Development Practices and FDA Compliance References [1] – FDA (2002). General Principles of Software Validation; Final Guidance for Industry and FDA Staff. FDA website: http://www.fda.gov/cdrh/comp/guidance/938.pdf [2] – Pietrasanta, Alfred M. (1990). Defect Prevention. Software Quality Improvement Module 9: Software Engineering Institute, Carnegie Mellon University. 85