Training activity information
Details
Undertake complex medical device or service-related risk assessments in accordance with ISO 14971.
Type
Entrustable training activity (ETA)
Evidence requirements
Evidence the activity has been undertaken by the trainee repeatedly, consistently, and effectively over time, in a range of situations. This may include occasions where the trainee has not successfully achieved the outcome of the activity themselves. For example, because it was not appropriate to undertake the task in the circumstances or the trainees recognised their own limitations and sought help or advice to ensure the activity reached an appropriate conclusion.
Reflection at multiple timepoints on the trainee learning journey for this activity.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 3 |
Outcome
Apply risk management strategies to the management of healthcare technology to ensure the safety of patients and healthcare professionals. |
| # 4 |
Outcome
Appraise and apply legislative frameworks for healthcare technology management. |
| # 5 |
Outcome
Practice in accordance with organisational policy for healthcare technology management. |