The Docking Station, Teirstein Edge and AngioAssist are three medical devices used to introduce and organize guide wires and catheters during interventional cardiovascular procedures. Fallbrook Engineering assisted with the design and development of these devices.

Working with Shepherd Scientific's patent drawings and concept prototypes, Fallbrook Engineering created a design concept, conducted concept testing and selected qualified vendors to build SLA models and preproduction tooling for initial bench testing. Fallbrook Engineering coordinated sterilization validation for the development of packaging testing and created all packaging labeling, as well as selected all machine shops, molding shops, test labs and facilities used for the project. In addition to working with their selected vendors, Fallbrook Engineering worked closely with Shepherd Scientific's regulatory advisers to provide the required engineering specifications and information for a 510(k) submission, and assisted to maintain the quality manual, design history file and device master record.

The Docking Station, Edge and AngioAssist are available from Shepherd Scientific, Inc., and Vascular Solutions, Inc.

www.shepherdscientific.com

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