Competency information
Details
Apply relevant legal, professional and ethical requirements of making devices for patients with oral cancer.
Considerations
Quality Management Systems
- Background to quality management systems.
- Quality management principles applied to quality management system standards.
- The ISO 9000 series of standards.
- Interpretation of quality management system standards: examples of generic standards and standards for organisations associated with medical devices.
Product Liability
- Introduction to product liability legislation, UK and European remedies.
- European law, types of EU law, new approach standards.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 | Outcome Select, justify, use and evaluate a range of biomedical materials in the manufacture of a variety of custom-made medical devices. |
| # 2 | Outcome Design and manufacture devices to support radiotherapy in accordance with appropriate quality systems and work safely in radiation areas. |