Competency information

Details

Apply relevant legal, professional and ethical requirements of manufacturing devices used for maxillofacial trauma.

Considerations

  • Maintenance of contemporaneous device manufacturing records.
  • Medicines and Healthcare products Regulatory Agency (MHRA) requirements for laboratory records.
  • Completion of statement of conformity Medical Device Directives (MDD).

Relevant learning outcomes

# Outcome
# 4 Outcome Plan and manufacture devices for a range of patients with facial fractures.