WOMED SAS

Daniel & Daniel Consulting (operating as WOMED SAS) is a boutique clinical and regulatory medical device consulting firm with 35+ years of experience (since 1988). The firm specializes in FDA submissions, clinical trial design, European CE Mark applications, and regulatory compliance strategy for medical device companies. Core competencies include 510(k) clearances for combination device/drug products, De Novo submissions for novel devices including robotic-assisted surgical systems, Software as Medical Device (SaMD) regulatory pathways covering AI/Deep Learning diagnostics (ECG analysis, X-ray fracture identification, brain imaging), and pre/post-market clinical studies as a Clinical Research Organization (CRO). The firm also provides regulatory and clinical affairs education, teaching at Stanford University's biomedical engineering program.