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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 510(k) clearance from FDA for "Imaging of tissue microstructure, including but not limited to, cells, vessels, and their organization and architecture."

FDA PMA approval for artificial heart system..

Teachingt annual Bio-medical regulatory class at Stanford University (6th year).

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

Obtained clearance for 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 clearance of a robotic bronchoscope in 2017.


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