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
Acknowledgments• P/L Biomedical, Mr. Lee Leichter• Radius Product Development, Ms. Christina Mendat, Mr.Sean Phillips• Talmed ltd., Ms. Tali Hazan• Our colleagues:Guy Keenan – device testingLior Raday, Udi Carmel, Micha Segev, Amotz Porat – R&DShay Shaham, Ms. Sina Harshuk – QA &RAAmit Shlezinger, Yuval Paz - Operationsand many others…34
Contacts• Dr. Menachem Zucker, VPHead of Injectable Drug Delivery Devices (I3D)menachem@elcam.co.il• David Daily,Director for R&D and BD, I3D, Elcam MedicalCEO, DALI Medical Devicesddaily@dalimed.com35
- 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 and 32: Flexi-Q DV Design Characteristics -
- Page 33: Visit us @ Booth 320Summary: Elcam
Acknowledgments• P/L Biomedical, Mr. Lee Leichter• Radius Product Development, Ms. Christina Mendat, Mr.Sean Phillips• Talmed ltd., Ms. Tali Hazan• Our colleagues:Guy Keenan – device testingLior Raday, Udi Carmel, Micha Segev, Amotz Porat – R&DShay Shaham, Ms. Sina Harshuk – QA &RAAmit Shlezinger, Yuval Paz - Operationsand many others…34
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