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
Lessons learned• Formative Study vs. Summative Study• No need for quantitative measurements in the usabilitystudy!!!• 100% success only in steps which were identified as critical(Risk Assessment). In other steps failures are allowed aslong as they are not systemic.• HAQ as acceptable approach for disease level classification.• Provide documentation in a format that is consistent with therecent release of the New Draft Human Factors Guidanceeven-though still a “draft”.• Pre-IDE does not guarantee zero issues with FDA…32
Visit us @ Booth 320Summary: Elcam Medical• Differentiator• Fight drug counterfeiting• Improved life-cycle management• IMPROVED Patient ComplianceYou needUnique, Customizable NEW GENERATION Flexi-Q linefor low-high viscosity, liquid or lyophilized,for both Pre-filled Syringes & Vials33
- 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 14 and 15: Device and Changes Validation• Si
- 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: Flexi-Q DV Design Characteristics -
- Page 35 and 36: Contacts• Dr. Menachem Zucker, VP
Visit us @ Booth 320Summary: Elcam <strong>Medical</strong>• Differentiator• Fight drug counterfeiting• Improved life-cycle management• IMPROVED Patient ComplianceYou needUnique, Customizable NEW GENERATION <strong>Flexi</strong>-Q linefor low-high viscosity, liquid or lyophilized,for both Pre-filled Syringes & Vials33
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