This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

MedTech Summit
16 - 20 June 2025
Mercure Hotel MOA Berlin, Berlin, GermanyHybrid Event I Attend In-Person Or Digitally

James Shearn
Director, Regulatory & Quality Compliance (EMEA) at Steris
Speaker, Advisor

Profile

James Shearn has a degree in Medical Electronics and has worked in the Medical Devices and In Vitro Diagnostic Devices (IVD) sector for more than 27 years. His early career was in medical device research and development, before shifting focus to Regulatory Affairs. Throughout his career James has held roles with several large manufacturers, working in the fields of drug infusion systems, cardiology and diabetes management. His most recent IVD space roles was Vice President Regulatory Affairs & Quality Assurance at Oncimmune, an immunodiagnostics company with a focus on the early detection of cancer and autoantibody profiling of autoimmune and infectious diseases. James has also worked as an independent regulatory consultant, predominantly with Small and Medium Sized Enterprises (SMEs). In February 2023, joined Steris as Director, Regulatory & Quality Compliance (EMEA).


Agenda Sessions

  • Chairperson’s Opening Remarks: European Medical Device Regulations

    08:30
  • Chairperson’s Afternoon Remarks: European Medical Device Regulations

    14:10
  • Elevating Efficiencies: Can We Make the MDR More Efficient?

    17:00