Flexi-Q DV Auto-injector Case Study - DALI Medical Devices

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FDA 510(k) Clearance• SE letter (Feb 2012)July2009Feb’2010Nov’2010May2011July2011Jan’2012Feb’201228
Flexi-Q DV Design Characteristics -Pharmaceutical Customer AdvantagesDifferentiation:• Unique auto-injector for drugs in vials• Compatible with drugs withdifferent administration volumesFlexi-Q DVR and P-DVR versions*:• Allow reconstitution of multiple vialsfor increased drug dosing / mixing• Provides flexibility – the diluents may bein either vials or pre-filled in the injector* Require additional submission(s)29
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: Study Conclusions• The study resu
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

Flexi-Q DV Auto-injector Case Study - DALI Medical Devices

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