Authorising Engineer Medical Engineering

Course Aim The aim of this course is: ‘To equip experienced engineers, who are seeking appointment as an AE(ME), with the behaviours, knowledge and skills required to be effective as an Authorising Engineer, Medical Devices Engineering’

Description

Course Training Objectives

By the end of this course, you will be able to:

  1. Explain the roles played by various regulatory bodies (MHRA, CQC, HSE) and individual roles in UK healthcare
  2. Accurately describe the function of a Medical Device Management System (MDMS) and identify potential weaknesses
  3. Identify the problems associated with procurement & replacement equipment programs for medical devices
  4. Apply the principles, reasons for non-compliance and advanced topics when conducting a medical device technical audits
  5. Discuss the distribution, format, methods of feedback and application of RAG ratings within audit report writing
  6. Demonstrate knowledge of the statutory, mandatory reporting systems and process for investigation of medical device Incidents/ Accidents