Competency information

Details

Provide advice on the requirements for a clinical trial involving a novel medical device

Considerations

  • The institution’s R&D approval process and the requirements of MRHA
  • How to design, execute and report a medical device-related research project
  • Differences between research and evaluation, the latter relating to trialling products that have already been proven to be clinically effective

Relevant learning outcomes

# Outcome
# 6 Outcome Advise on ad-hoc technical issues