2013 State of medical device webinar
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Transcript of 2013 State of medical device webinar
![Page 1: 2013 State of medical device webinar](https://reader033.fdocuments.in/reader033/viewer/2022052901/556ae979d8b42a86218b4bcf/html5/thumbnails/1.jpg)
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
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Survey Demographics
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Top 10 Time-Consuming Tasks
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Needed Visibility
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Still Mostly Document-Centric
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Risk Management Tools
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Risk Management Methods
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Risk Traceability
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Requirements Management
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Test Management
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Traceability Matrix
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Traceability Management
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Top Issues Preventing Improvement
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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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