Sophie has 8 years of experience working with Medical Devices. She holds a Bachelor of Science degree in Biomedical Science from the University of Sheffield.
During her carer she has work with combination of Pharmaceutical and Medical Device quality control testing within GLP, GMP and FDA accredited setting. During this time, she trained in cytotoxicity testing, endotoxin testing, microbiological quality and other cell-based in-vitro toxicology assays. She was appointed as a GLP Study Director, conducting cytotoxicity studies and multi-site studies for medical device submission. She was involved in designing bespoke testing solutions for complex products, method verification,
Prior to joining Test Labs, Sophie was working as a Regulatory Affairs Consultant specialising in UK MDR 2002 (as amended), MDD 93/42/EEC, IVDD 98/72/EC, MDR 2017/745 and IVDR 2017/746. Biological evaluation, risk management, clinical evaluation, and device registrations in the UK and EU.
Here at Test Labs, she is a Senior Study Manager focussing on biological evaluation and biocompatibility testing as a GLP study director.
