Competency information
Details
Participate in the investigation of a medical device incident within the organisation
Considerations
- Organisational requirements for incident reporting.
- How to report an incident to the MHRA and other organisations as necessary.
- The forensic approach to incident investigation and the key elements of an investigation.
- Information to capture in relation to a medical device incident.
- Gain an appreciation of root cause analysis.
- Typical incidents that have occurred with medical devices via study of MHRA reports.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 4 | Outcome acceptance test and commission a new medical device |