Director of Global Quality & Accreditation, Regulatory Services
BSI, England, United Kingdom
Linda leads BSI's oversight and management of the core accreditations for Medical Devices, Artificial Intelligence and Product Certification that support the Regulatory Services Division's activities. She leads BSI's management of the Medical Device Single Audit Programme (MDSAP) including strategic liaision with key regulators such as the Therapeutic Goods Administration and Food and Drug Administration.
She provides Medical Device Quality Management System, AI Management System and Accreditation Management leadership to BSI QMS and AIMS Assessment teams globally, working across a range of teams - both within the Regulatory Services Divison and across the wider BSI - to ensure the relevant processes are in place to meet all Quality and Accreditation regulatory obligations.
She originally joined BSI in 2001 as a QMS auditor and became an IVD Technical Specialist & Scheme Manager in 2010 prior to moving to the Global Quality & Accreditation team in 2015 where she became the head of the team in 2021.
Prior to joining BSI, Linda worked at NIBSC in testing and batch release of vaccines, IVD research and QMS accreditation to ISO 17025.
She holds an MPhil. and BSc.(Hons) in Pharmacology from the University of Liverpool.
Linda is an active member of the ISO and UK standards committee for quality management for medical devices (ISO13485).
Singing in Harmony: Leveraging MDSAP to Synergize your QMS
Wednesday, May 6, 2026
10:45 - 11:45 WEST