Louise Olliver has more than 30 years’ experience in regulatory affairs and quality management in the fields of medical devices, in vitro diagnostics and pharmaceuticals. Her qualifications include a PhD in Molecular Biology, an M.Sc. (Chemical Pathology) and BSc (Med) (Hons) Biochemistry and Microbiology.
Her consultancy business was established in 1989 and has been engaged by a broad range of clients from small-scale start-up companies, consultancies, to blue-chip corporations. As a member of the EU Technical Committee TC 210 Quality Management Systems and Risk Analysis for Medical Devices she contributes to reviews and revisions of EN ISO 13485 and EN ISO 14971. Louise has partnered on H2020 consortia and speaks at professional conferences and delivers bespoke in-house training.