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GMTA Perspective Continuous improvement product safety and performance
IMDRF Open Session Brussels, 13 November 2013 Jesús Rueda Rodríguez
The Virtuous Circle
- f Quality Care
How do medical devices fit in?
safety and performance IMDRF Open Session Brussels, 13 November - - PowerPoint PPT Presentation
safety and performance IMDRF Open Session Brussels, 13 November - - PowerPoint PPT Presentation
GMTA Perspective Continuous improvement product safety and performance IMDRF Open Session Brussels, 13 November 2013 Jess Rueda Rodrguez Health Systems Focus on Quality of Care The Virtuous Circle of Quality Care How do medical
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Reactive Proactive Obtaining Data
Scientific Literature User Complaints Adverse Reports On-going Usability Studies Regulatory Guidance Standards Engagement with KOL Centres of Excellence Post Market Studies On-going Research (internal & external) Clinician & Patient Focus Groups
Improving Safety and Performance of Medical Devices
Patient focus groups and usability studies are of particular importance for devices intended for lay users
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Risk Management Quality Management Is a change indicated? Improved Performance Safer Devices
Improving Safety and Performance of Medical Devices
Systematic Approach Better Usability Solutions to Healthcare Problems
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Examples – improving medical devices
1-2 yrs
209 cc 72 cc
4-5 yrs
39 cc
3-4 yrs 6-7 yrs
35 cc
8-9 yrs
40 cc
Size Battery Life
Major increase in functionality
Images of pacemakers from Medtronic
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Conclusion
Through a Systematic Quality and Risk Management – Data Driven Approach Collaborative approach with Health Care Systems