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

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Verification TestsPerformance Testing: Forces• Retraction to enable injection• Button Activation• Needle Shield Protection• etc.NS ProtectionunderSide ForcePerformance Testing: Syringe related• Injection Time• Dead Volume• Needle Penetration Depth• etc.Pre-Conditioning:• Storage Environmental Conditions• Dry Heat Atmosphere (70°C)• Cold Storage Atmosphere (-40°C)• Drop 1m height• Transportation - Shipping &HandlingPerformance Testing: Shelf Life• Accelerated Aging• Stability Tests12
Needle Shield Protection under Side Force• Specific test protocol• Acceptance Criterionaccording to product SPEC• Special designed fixtures13
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 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 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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