Competency information
Details
Apply risk analysis iteratively to improve and redefine a design.
Considerations
- The relevant range of standards and their application (ISB 0129, MDD, 80001, IEC 62304:2006 and EN14971, etc.).
- Relevant development methodologies (e.g. Waterfall, Agile) and their comparative merits and applicability.
- The practical relevance and implementation of safety standards (see above list).
- Risk analysis methods and techniques, including hazard workshops.
- How 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 clinical software.
- 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 (ICT) projects within the Physical Sciences. |