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2013 state of medical device webinar

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

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Page 1: 2013 State of medical device webinar

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

Page 2: 2013 State of medical device webinar

Survey Demographics

Page 3: 2013 State of medical device webinar

Top 10 Time-Consuming Tasks

Page 4: 2013 State of medical device webinar

Needed Visibility

Page 5: 2013 State of medical device webinar

Still Mostly Document-Centric

Page 6: 2013 State of medical device webinar

Risk Management Tools

Page 7: 2013 State of medical device webinar

Risk Management Methods

Page 8: 2013 State of medical device webinar

Risk Traceability

Page 9: 2013 State of medical device webinar

Requirements Management

Page 10: 2013 State of medical device webinar

Test Management

Page 11: 2013 State of medical device webinar

Traceability Matrix

Page 12: 2013 State of medical device webinar

Traceability Management

Page 13: 2013 State of medical device webinar

Top Issues Preventing Improvement

Page 14: 2013 State of medical device webinar

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

Page 15: 2013 State of medical device webinar

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