Roberta Druyor-Sanchez

Bobbi Druyor-Sanchez, MS, is a Partner with NDA Partners and has worked with the company as an Expert Consultant since 2014. She is a bioengineer with expertise in both regulatory affairs and quality assurance with an emphasis on software as a medical device (SaMD), telemedicine, ophthalmic, and supporting the convergence of CLIA based Laboratory Developed Tests (LDT) to FDA in vitro diagnostic tests including bioanalytic implementation. This includes defining technical and product direction in early-stage companies, 510(k) and De Novo clearance submissions, implementing medical device quality systems including QSR, ISO 13485, and MDD/CE Mark Certification Quality Management Systems (QMS).

Ms. Druyor-Sanchez was formerly Director of Quality and Regulatory at MedApps Inc./Alere Connect, and Vice President of Quality and Regulatory at Exsomed. Before joining MedApps, she was Director of Systems Integration Engineering at Rose Street Labs/Kemeta LLC, and has held senior engineering positions at Motorola/Amersham/GE Healthcare, IMPRA (a subsidiary of C.R. Bard) and Ventana Medical Systems. For three years she was part of the mHealth (MRC) and CDS Coalitions, whose goal was to be a thought leader in mHealth and Clinical Decision Software ecosystems. These Coalitions worked with FDA, FCC, and IT Health to define policy such as the new MDDS and MMA guidances as well as the FDASIA report.