Competency information
Details
Apply the regulatory factors affecting the recording and provision of deep-buried implants.
Considerations
Risk Management and Governance
- National and international standards and guidance particularly in relation to in-house (within the same hospital as the device is to be fitted) and commercial manufacture.
- Compliance with the requirements of the Medical Devices Directive (MDD).
- The requirements of the MDD and the application of these and technical standards to the safety and performance of medical devices.
- Device classifications.
- Clinical Governance framework.
- Current standards and compliance in the healthcare environment including Standards for Better Health, NHS Litigation Authority.
- Management of innovation and prototypes.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 10 | Outcome Manufacture medical implants for patients requiring surgical repair. |