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Michelle Kelly
Senior Medical Device Specialist, ISO TC/194 Member at MHRA

Profile

Michelle is the Biological safety Manager for the Devices Division at MHRA. She has overall responsibility for the conduct and outcome of biological safety assessments undertaken for clinical investigation notifications submitted to the UK medical device Competent Authority. She also leads on all toxicological projects and investigations undertaken by the Devices Division. She is currently leading the toxicological decision-making process for devices submitted to the UK government under the “fast-track approval of medical devices during COVID-19 process” . She is responsible for developing the minimally acceptable biological safety requirements for the air pathway of a rapidly manufactured ventilator published on the government website at the start of the pandemic. She is currently the chair of CH/194, the committee representing UK in the development of standards for biological safety and clinical evaluation.

Agenda Sessions

  • Regulator View: Assessment and review by “knowledgeable and experienced professionals” and Fast-track approval of medical devices

    14:00