Our 35+ years of experience in the industry as both consultant and client has given us the expertise to tackle your toughest challenges, from design through regulatory and everything in between.
Georgiann Keyport, MS, RAC, ASQ, CBA
Georgiann has an undergraduate degree in Biology and a Masters Degree in Laboratory Medicine with experience in product development, quality control, quality assurance, regulatory and clinical affairs. She has over 29 years of expertise in the medical device, drug and biologics industries; providing services in regulatory product strategy, domestic and international submissions, global quality compliance auditing and system development. Georgiann’s background and experiences have allowed her to provide creative approaches and practical solutions to meet regulatory compliance worldwide.
Debbie Barber, MS
Debbie has an undergraduate degree in Biomechanics and a Masters Degree in Engineering Mechanics and significant experience in product development and the evaluation of products at all stages of the design process. With over 14 years of experience in the medical device industry, she has utilized successfully an integrated approach to product development and project management that considers both the clinical and technical aspects of medical devices throughout the product life cycle. She has experience in multiple areas that are applicable to this current project including: R&D, product development, project management, risk management, preclinical studies, verification and validation studies and regulatory.