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Quality & Compliance Services Staff

• Judith Andrews, Ph.D, RAC, Director
• Affiliate Quality and Compliance Consultants
• John L. Webster, C.Chem, MRSC, Managing Director

Judith Andrews, Ph.D, RAC, Director
Judith has over twenty years of hands-on experience in the FDA regulation of medical devices. Judy has expertise with in vitro diagnostic devices and over-the-counter medical products and has held positions in product development, manufacturing, quality control and quality assurance at several companies including a fortune 500 company and several start-up firms. Her demonstrated expertise in developing, implementing, and auditing quality systems, together with a “value-added” approach, is a strong fit for medical device manufacturers seeking to comply with QSR, ISO 13485:2003, MDD, IVDD, AIMD or Canadian Medical Device Regulation. She assists clients with recalls, U.S. and EU medical device reporting, and FDA 483s and warning letters. Judy holds a Ph.D. in chemistry from Case Western Reserve University and an M.B.A. from Simmons Graduate School of Management. She is a certified biomedical auditor and is Regulatory Affairs Certified. She serves on the board of the New England chapter of the ASQ Biomedical Division and speaks regularly at industry and professional conferences, seminars and webinars.

Affiliate Quality and Compliance Consultants
MDCI maintains a network of affiliate quality and compliance consultants with experience in quality systems, quality engineering, and regulatory compliance. They assist clients in the areas of medical device audits, process validation, design control, quality system consulting, and training, as well as software quality assurance, product software validation, software regulatory compliance and validation of automated processes.

MDCI Ltd.

John L. Webster, C.Chem, MRSC, Managing Director
John manages all activities of MDCI's UK office, which provides regulatory, clinical trial and quality assurance consulting support to EU and U.S. clients and serves as EU authorized Representative for a large number of medical device manufacturers. John has over thirty years of quality assurance, regulatory, and management experience. Prior to joining MDCI in 1997, he was director of regulatory affairs in Europe for Boston Scientific, Paris, France and director of regulatory affairs Europe, Middle East and Africa at Meadox Medical Inc. John is a chartered chemist, member of the Royal Society of Chemistry (C. Chem, M.R.S.C.), a lead assessor, Lloyds Quality Management System Assessment and a certified quality engineer, American Society of Quality. He is a member of the Regulatory Affairs Professionals Society (RAPS) and serves on the RAPS European Regional Operating Committee (EUROC). He served as vice chairman technical for the European Confederation of Medical Device Manufacturers (EUCOMED) during the evolution of the Medical Device Directive. He is a graduate of the Royal Institute of Chemistry, Newcastle Upon Tyne University and has a diploma in management studies from the University of East Anglia. John speaks regularly at professional conferences. He is Regulatory Affairs Certified.