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Medical Device Quality Enhancement An Industry Perspective
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Transcript of Medical Device Quality Enhancement An Industry Perspective
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Donna GodwardChief Quality OfficerJohnson & JohnsonMedical Devices & Diagnostics
Medical Device Quality EnhancementAn Industry Perspective
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Goal• To improve product safety and
quality, at lower total quality cost
Engagement:• How can Industry and FDA interact to
identify way to focus on Quality
Medical Device Quality EnhancementAn Industry Perspective
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Medical Device Quality Enhancement: An Industry Perspective• Clear priorities, aligned goals and objectives
– Shifting the focus to quality from compliance– Evolve regulatory models to promote device quality
and aligning industry and FDA to “Focus on Quality”
– Achieve a preventative model with agreed Risk-Benefit framework– Improve our ability to measure quality and early indicators
– Improve education and awareness within industry, – Clarify and communicate the “Case for Quality”– Identification and validation of Quality practices
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Medical Device Quality Enhancement: An Industry Perspective• FDA and Industry engagement
– Coalition for • Enhancing medical device quality• Transparency• Engagement
– Work streams• Risk-benefit decision making• Quality benchmarking, CTQ & root cause• National and Local forum planning
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• Leadership from FDA and Medical Device companies
• Strong foundation for “productive relationships”
• Dialogue between FDA and Medical Device companies
• Focus on Quality
Medical Device Quality EnhancementAn Industry Perspective
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Medical Device Quality EnhancementAn Industry Perspective
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