Ms. Harris has over 25 years of industry experience including project management and data analysis roles in highly technical environments. Ms. Harris joined Daniel & Daniel Consulting in 2003. Prior to joining Daniel and Daniel Consulting Cindy worked in the Oil and Gas Industry as a geophysicist, Project Manager of multidisciplinary teams and as Chief Geophysicist for major oil companies. Earlier experience includes work with private practice physician teams in community settings. As Manager, Clinical Affairs, Ms. Harris has been responsible for a number of projects including:
· Percutaneous Coronary Catheter 510(k) preparation
· Drug pump and catheter IDE submission
· Intravascular catheters - three site Randomized Clinical Study
· ECG signal processing - FDA 510(k) preparation and clearance negotiation
· Left Atrial Appendage Occlusion Device - four site single arm Clinical Study
· Semi-automated colonoscope and NOTES projects
· Coronary catheter projects - Clinical Studies / 510(k)
· Exercise equipment project – 510(k) review and clearance