Competency information

Details

Develop technical documentation for development of a medical device

Considerations

  • Requirements of the MDD and local guidelines

Relevant learning outcomes

# Outcome
# 2 Outcome Specify, design, build and bring into service pieces of equipment, using formal design processes, to be used either (a) in a biomechanical or functional assessment, including validation against current clinical methods, or (b) to meet a specific clinical need for a particular clinical problem, including measurement of performance
# 3 Outcome According to established standards, develop and keep up to date the associated documentation, including those relating to technical construction and risk management