Dcn Bios > Corporate Strategy, Technology Assessment, Gap Analysis & High Level Quality System
Corporate Strategy, Technology Assessment, Gap Analysis & High Level Quality System
Strategic and board level market and technology advice based on 20 year’s experience at high levels within industry leaders including Quidel, Inverness Medical Innovations and Response Biomedical Quality, regulatory compliance and operations professional with experience in designing, implementing, assessing and improving product and process life cycle systems, augmenting product development, quality and regulatory compliance, post-market and technical service, distribution activities and regulatory interface.
Specialties include compliance and quality system development and implementation, audit/assessment and improvement under USFDA, ISO, EU MDD and IVDD, CMDR and other requirements from start-up to post-market for medical devices and IVDs based on business, customer and product life cycle compliance and strategic objectives.