Competency information
Details
Manage security, safety and business risk throughout the development, including the use of ALARP principles
Considerations
- The relevant range of development standards and their application (DSCN 14, MDD, 60601, 80001, IEC 62304:2006 and EN14971, etc)
- The practical relevance and implementation of safety standards (see above list)
- Risk analysis methods and techniques, including hazard workshops
- The ability to implement risk management standards
- The practical implications of clinical governance issues related to medical devices
- The practical implications of research governance issues related to medical devices
- Factors affecting security, safety and business risk, and how they influence the final design
- When registration of the solution is required and by whom
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 5 | Outcome Develop, critically evaluate and deliver novel solutions to clinical measurement, information and communication technology (ICT) and/or medical device requirements through the full project life cycle |