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

12.07.2015 • Views

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

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

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Elcam customers are the leading U.S. &European medical device companies4

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Elcam customers are the leading U.S. &European medical device companies4

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