Palo Alto, California, United States
Consultant to medical and life sciences companies, focusing on; • Product development, quality planning and execution • Regulatory strategy and execution for medical and in vitro diagnostic devices (FDA, MDD/IVDD, CMDCAS, TGA) • ISO14971 Risk Management compliance, process development, and training • IEC62304 Software Lifecycle compliance, processes and training • FDA QSR and ISO13485 compliance strategy, execution and training
Responsible for global Q&R organization (California and Germany), supporting devices for US, EC, Canadian and Australian markets.
Proposal-to-Product; lead growth, in 3.5 years, from 3 people and a concept, to a world-wide organization supporting commercial releases in 6 countries of a remote management platform for chronically ill patients. This system received numerous industry leadership awards, including o the 2005 Medical Design Excellence Award (MDEA), o the Frost & Sullivan Technology Leadership award for Telemonitoring, and o the Best Enabling Tool Award for Disease Management by the DMAA