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2013 State of medical device webinar
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
14. Providing Turnkey Software
Validation Solutions Since 2005
Product Software Development Lifecycle
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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
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Computerized Systems Validation
Equipment & Automated Systems Validation