Daniel & Daniel Consulting has been helping small to medium size medical device companies develop clinical and regulatory strategy, complete clinical studies, gain FDA product clearance / approval and apply the European CE Mark
Obtained FDA PMA approval for Vascular Closure Device.
Successfully completed FDA approved IDE multicenter studies for femoral access closure device, and Left Atrial Appendage Exclusion device.
Obtained 510(k) clearance for Laser imaging system for tissue
microstructure, and biliary and pancreatic duct imaging. Obtained 510(k)
clearance for vascular access device and Left Atrial Appendage Exclusion
Obtained 510(k) clearance for revisions to transoral device for tissue approximation in GI tract.Mr. Daniel presented "Clinical Trial Strategy for Success" at the recent MD&M conference. [video]