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Ginsbourg.com - Presentation of a Plan for Medical Device Software Validation and Verification

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Ginsbourg.com - Presentation of a Plan for Medical Device Software Validation and Verification

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Ginsbourg.com - Presentation of a Plan for Medical Device Software Validation and Verification

  1. 1. Ginsbourg.com Plan for Medical Device Software Validation and Verification 2014-2015 Ginsbourg.com MD SW V&V 2014-2015 July 24, 2014 1
  2. 2. Ginsbourg.com July 24, 2014 • Formerly QA Manager of LoadRunner at Mercury Interactive • M.Sc. cum laude in Bio-Medical Engineering • M.Sc. in Mechanical Engineering 2Ginsbourg.com MD SW V&V 2014-2015
  3. 3. Ginsbourg.com July 24, 2014 3Ginsbourg.com MD SW V&V 2014-2015
  4. 4. Ginsbourg.com 1. Coding finished 2. Run a few tests 3. System approved 4. Release Result: Disaster !  Inadequate design or poor coding produces many time bombs in the system! ← High Risk Approach July 24, 2014 4Ginsbourg.com MD SW V&V 2014-2015
  5. 5. Ginsbourg.com Therac-25 medical accelerator (1985-1987) • Therac-25 was a therapy system that delivered two different kinds of radiation: either a low-power electron beam or X-rays. • The Therac-25's X-rays were generated by smashing high-power electrons into a metal target positioned between the electron gun and the patient. • An electromechanical safety interlock was replaced by a software control, because software was perceived to be more reliable. • The OS was compiled by a programmer with no formal training. • Because of a “race condition” bug, the operator could accidentally configure the Therac-25 so the electron beam would fire in high-power mode, but with the metal X-ray target out of position. • At least five patients died; others were seriously injured. Catastrophic software failure July 24, 2014 5Ginsbourg.com MD SW V&V 2014-2015
  6. 6. Ginsbourg.com July 24, 2014 6Ginsbourg.com MD SW V&V 2014-2015 "I can’t tell you how many manufacturers I have seen that have tried to present their risk management system by simply presenting a FMEA. That is NOT a risk management system." Kimberly A. Trautman, QSR Expert, CDRH, FDA
  7. 7. Ginsbourg.com QC → Products QA → Processes ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes July 24, 2014 7Ginsbourg.com MD SW V&V 2014-2015
  8. 8. Ginsbourg.com ← Low Risk Approach 1.SW Lifecycle 2.Documentation 3.Risk Analysis 4.Specifications (functional, performance, usability, etc.) 5.Requirements (marketing, technical, user expectations, etc.) 6.Code Review (manual, automatic) 7.Code Freeze 8.Version Management 9.Bug Base 10.Validation & Verification July 24, 2014 8Ginsbourg.com MD SW V&V 2014-2015
  9. 9. Ginsbourg.com July 24, 2014 9Ginsbourg.com MD SW V&V 2014-2015
  10. 10. Ginsbourg.com July 24, 2014 10Ginsbourg.com MD SW V&V 2014-2015
  11. 11. Ginsbourg.com July 24, 2014 What are mobile medical apps? Mobile apps are software programs that run on smartphones and other mobile communication devices. How will the FDA regulate mobile medical apps? The FDA will apply the same risk-based approach the agency uses to assure safety and effectiveness for other medical devices. Last Updated: 10/22/2013 11Ginsbourg.com MD SW V&V 2014-2015
  12. 12. Ginsbourg.com July 24, 2014 When is a mobile app classed as a medical device? 12Ginsbourg.com MD SW V&V 2014-2015
  13. 13. Ginsbourg.com July 24, 2014 • Currently available for iOS devices. • Helps doctors calculate the percentage of a patient’s body surface area that is burned. • Calculates the amount of fluid to be administered in the 24-hour period that follows the burn injury. 13Ginsbourg.com MD SW V&V 2014-2015
  14. 14. Ginsbourg.com July 24, 2014 14Ginsbourg.com MD SW V&V 2014-2015
  15. 15. Ginsbourg.com July 24, 2014 15Ginsbourg.com MD SW V&V 2014-2015
  16. 16. Ginsbourg.com July 24, 2014 16Ginsbourg.com MD SW V&V 2014-2015
  17. 17. Ginsbourg.com July 24, 2014 17Ginsbourg.com MD SW V&V 2014-2015 10-step plan for medical device software validation and verification: 1. Perform risk analysis 2. Determine level of concern 3. Describe the software 4. Formulate requirements specifications 5. Develop design specifications inc. architecture design chart 6. Craft a software development environment summary document 7. Document validation and verification testing 8. Perform a traceability analysis 9. Determine unresolved anomalies 10.Maintain a log of revision and release numbers
  18. 18. Ginsbourg.com July 24, 2014 18Ginsbourg.com MD SW V&V 2014-2015
  19. 19. Ginsbourg.com July 24, 2014 http://www.ibm.com 19Ginsbourg.com MD SW V&V 2014-2015
  20. 20. Ginsbourg.com July 24, 2014 20Ginsbourg.com MD SW V&V 2014-2015
  21. 21. Ginsbourg.com July 24, 2014 21Ginsbourg.com MD SW V&V 2014-2015

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