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Sophie Clewlow
Higher Medical Device Specialist, ISO TC/194 Member at MHRA


Sophie is a Biocompatibility Specialist working as part of the Biological Safety team under the Devices Division at the Medicines and Healthcare products Regulatory Agency (MHRA). She is responsible for assessing biological safety evaluations and toxicological risk assessments according to ISO 10993 and the regulations. Her role includes investigating toxicological signals associated with the use of medical devices. She has achieved a BSc (Hons) Biochemistry and is working towards an MSc in Medical Toxicology. She is also part a committee member for CH/194 ISO 10993.

Agenda Sessions

  • Impact of the EU MDR and ISO 10993-1:2018 on biological evaluation of medical devices