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

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Project History -General Top Level Overview2003 -20042004 -20052005 -20092009Feb2012I3DinitiativeFeasibilityFUDAIPFS+DV,SEDAI, AN:Prototypes, IP,road show at9 pharmas(EU+US)DevelopmentFocusedinitially on DVFlexi-Q PFS– FDADeviceMaster File(MAF)Flexi-Q DV– 1 st 510(k)SubmissionFlexi-Q DV– 510(k)CLEARED7
Page 1: Visit us @ Booth 320Flexi-Q DV Auto
Page 8: Initial Development Phase• Develo
Page 11 and 12: Chosen Solution1. Implementing a De
Page 13 and 14: Needle Shield Protection under Side
Page 15 and 16: Study Methodology - Brief1. Devices
Page 17 and 18: Pre-IDE• FDA review: Main issue w
Page 19 and 20: Usability Study• Question to CDRH
Page 23: Study Participants• Procrit ® -
Page 26 and 27: Study Results• Observed Practice
Page 28 and 29: FDA 510(k) Clearance• SE letter (
Page 30 and 31: Flexi-Q DV Design Characteristics -
Page 32 and 33: Lessons learned• Formative Study
Page 34 and 35: Acknowledgments• P/L Biomedical,
Page 36: Visit us @ Booth 320Thank You

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

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