Clinical Investigation Under the Medical Device Regulation (MDR)

Clinical Investigation Under the MDR

View On-Demand Webinar

View On-Demand Webinar

With the release of the third edition of ISO 14155, and the implementation of the EU MDR, clinical performance or effectiveness and safety of medical devices are central to the outcome of clinical investigation.

In this webinar, our expert discusses the relevance of ISO 14155 to EU MDR and key aspects to comply with the standard.

Complete the form to watch the on-demand webinar!


key topics covered:

  • Performance and clinical performance
  • Types of designs that are relevant for the EU MDR as provided in the ISO 14155
  • The requirements for clinical data to be transferable
  • Difficulties and opportunities/solutions associated with clinical investigation 

About the speaker

Dr. Vera Wells M.D.

Clinical Expert/Auditor, TÜV SÜD Canada

Dr. Wells is a Medical Expert with more than ten years of experience in Clinical Medicine. She also has experience in Public Health and Health Informatics / IT industries, supporting other Clinicians to assess compliance to Healthcare Regulatory Requirements in the implementation of Electronic Healthcare Record software systems in hospitals and clinics in the USA.

Currently, she is the Program Lead for Clinical Auditing for TUV SUD MHS North America. Besides her role as a clinical auditor, she works as a clinical reviewer for the Clinical Centre of Excellence.

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