Competency information
Details
Apply the requirements of the Medical Devices Directive and appropriate standards and legislation to the design and manufacturing process
Considerations
Relevance of Medical Devices Directive (MDD) Essential Requirements to medical devices, including custom made devices
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 | Outcome Bring new items of equipment, systems, facilities and protocols into service safely and effectively |
| # 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 |