Competency: 9

Details

Follow the requirements of an appropriate development methodology.

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