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.
De Novo submissions and grants for a variety of devices without predicates including Robotic Assisted Surgical Devices (RASD) and others.
510(k) clearances for Combination device/drug products.
10th year of teaching regulatory and clinical affairs to one of the most popular Stanford University classes (biomedical engineering).
Additional 510(k) clearances for Software as Medical Device (SaMD) products including AI/Deep Learning systems for ECG analysis, X-ray fracture identification, and brain structure analysis.
Pre and post market clinical studies as the Clinical Research Organization (CRO).
