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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 new 785nm diagnostic Laser 510(k) clearance from FDA

Obtained FDA PMA approval for Vascular Closure Device.

Taught annual Bio-medical regulatory class at Stanford University

New FDA Guidance on 510(k) "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" [link to pdf]

Daniel & Daniel Consulting, LLC has been recently working with FDA to clear advanced imaging devices capable of visualizing tissue microstructure both ex-vivo and in-vivo.   We have also been working with the Agency to clear advanced cloud-based expert ECG pattern recognition software for analysis of cardiac function and identification of abnormalities

We continue our work with Robotics devices with the recent clearance of a robotic bronchoscope.

 

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