Flexi-Q DV Auto-injector Case Study - DALI Medical Devices
Flexi-Q DV Auto-injector Case Study - DALI Medical Devices Flexi-Q DV Auto-injector Case Study - DALI Medical Devices
Device and Changes Validation• Simulated Clinical Use (Summative) Study• Performed based on the FDA CDRH Guidance:“Medical Devices With Sharps Injury PreventionFeatures”14
Study Methodology - Brief1. Devices tested:500 units of Flexi-Q DV auto-injectors2. 30 total naïve participants recruited:– 5 participants being mild to moderate RA/MS patients– Male and female aged 18-70 years old3. Each participant operated 15-17 Flexi-Q DV’s:– Injecting into foam-pad positioned:on her/his thigh (~½);on her/his abdomen (~½);15
- Page 1: Visit us @ Booth 320Flexi-Q DV Auto
- Page 7 and 8: Project History -General Top Level
- Page 10 and 11: The Problem• In a usability study
- Page 12 and 13: Verification TestsPerformance Testi
- Page 16 and 17: Results1. No drug spillage has occu
- Page 18 and 19: Usability Studies• Previous Issue
- Page 20: New 510(k) submission• Usability
- Page 25 and 26: Study Procedure• Training by Heal
- Page 27 and 28: Study Conclusions• The study resu
- Page 29 and 30: Flexi-Q DV Design Characteristics -
- Page 31 and 32: Flexi-Q DV Design Characteristics -
- Page 33 and 34: Visit us @ Booth 320Summary: Elcam
- Page 35 and 36: Contacts• Dr. Menachem Zucker, VP
Device and Changes Validation• Simulated Clinical Use (Summative) <strong>Study</strong>• Performed based on the FDA CDRH Guidance:“<strong>Medical</strong> <strong>Devices</strong> With Sharps Injury PreventionFeatures”14
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