HLT.05.02officeUnion-wide competence
Purpose and competence
Medical-device use finding is maintained for Medical device review. Its scope follows the office’s mandate: Assess a medical device's claimed function, intended users and supported receiving setting.
A device tested in one environment is proposed for a materially different care setting
Record specification
Custodian and access
Medical device review assessment lead → · Public records access procedureFinding and assessment question
- Instrument
- Medical-device use finding
- Illustrative question
- A device tested in one environment is proposed for a materially different care setting
- Assessable source material
- device tests; intended use; clinical hazards