Ms. Druyor-Sanchez’s expertise in medical device development, quality management systems, and regulatory submissions has been highly valued by our clients and her leadership as a Partner in the firm will play a critical role as we expand our development program management services.
ROCHELLE, Va. (PRWEB) October 25, 2017
NDA Partners Chairman Carl Peck, MD, announced today that Roberta Druyor-Sanchez, MS, a bioengineer with expertise in the development of medical devices and novel biotechnology products, has been appointed a Partner in the firm. Ms. Druyor-Sanchez has worked with NDA Partners as an Expert Consultant since 2014. She was formerly Director of Quality and Regulatory at MedApps Inc./Alere Connect and Vice President of Quality and Regulatory at Exsomed.
Before joining MedApps, Ms. Druyor-Sanchez was Director of Systems Integration Engineering at Rose Street Labs/Kemeta LLC, and has held senior management and 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 Regulatory Coalition and Clinical Decision Support Coalition. These coalitions worked with the US Food & Drug Administration, Federal Communications Commission, and HealthIT to define policy such as the new Medical Device Data Systems (MDDS) and Mobile Medical Apps (MMA) regulatory guidances, as well as the Food & Drug Administration Safety and Innovation Act (FDASIA) report.
Ms. Druyor-Sanchez is an expert in defining technical and product direction with a focus in start-up company environments, implementing FDA’s QSR, ISO 13485, and MDD/CE Mark Certification Quality Management Systems (QMS), 510(k) clearance submissions, and engineering/ software systems.
According to Dr. Feigal, Manager of NDA Partner’s Medical Device Practice, “Ms. Druyor-Sanchez’s expertise in medical device development, quality management systems, and regulatory submissions has been highly valued by our clients and her leadership as a Partner in the firm will play a critical role as we expand our development program management services. We are very pleased to welcome her as Partner in the firm.”
Ms. Druyor-Sanchez earned both a BSE and MS in Biomedical Engineering with an emphasis in biochemistry from Arizona State University.
About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.
Earle Martin, Chief Executive Officer