BSI has a dedicated Medicinal and Biologics team, which provides guidance on drug-device combination products, conformity assessments of medical devices with ancillary medicinal substances (MDR Rule 14), and substance-based medical devices (MDR Rule 21).
Led by Dr Jennifer Durrant, Global Head of Medicinal and Biologics, who worked on the BSI General Devices team for over nine years previously, the team has over 55 years' combined experience in drug development, Good Manufacturing Procedures (GMP) systems and controls, and Quality by Design (QBD).