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
since 1988.
Obtained unconditional IDE approval from FDA for a randomized, multi-center, femoral artery closure device trial
Successfully completed FDA approved IDE multicenter study of Left Atrial Appendage Exclusion device.
Obtained 510(k) clearance for Left Atrial Appendage Exclusion device.
Obtained 510(k) clearance for revisions to transoral device for tissue approximation in GI tract.
Mr. Daniel was an invited participant in the recent FDA round table discussion during FDA's "Strengthening the 510(k) review process" meeting in Gaithersburg MA. [video]
