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