2013 State of medical device webinar

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This is the " 2013 State of Medical Device Webinar."

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2013 State of medical device webinar

  1. 1. The State of Medical Device Development Overview of Survey Results An analysis of the 2013 Medical Device Development survey results with insights from industry expert, Gregory Pierce of EngiSystems
  2. 2. Survey Demographics
  3. 3. Top 10 Time-Consuming Tasks
  4. 4. Needed Visibility
  5. 5. Still Mostly Document-Centric
  6. 6. Risk Management Tools
  7. 7. Risk Management Methods
  8. 8. Risk Traceability
  9. 9. Requirements Management
  10. 10. Test Management
  11. 11. Traceability Matrix
  12. 12. Traceability Management
  13. 13. Top Issues Preventing Improvement
  14. 14. Providing Turnkey Software Validation Solutions Since 2005 Product Software Development Lifecycle • • • Design Controls Quality System Process Development Medical Device Software Verification & Validation Medical Device Software Development Compliance • Class II, Class III • Following IEC 62304 • Meeting FDA Requirements Non-product Software • • Computerized Systems Validation Equipment & Automated Systems Validation

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