Medical Device Certification (UG)

Module aims

This course is aimed at teaching key information and skills needed by professional engineers in the development of medical systems and devices; specifically in the preparation of a project for CE certification (or regulatory approval in the appropriate environment)

Its major components are:

  • The regulatory framework, environment and procedures
  • Product Development for medical devices 
  • Safety, hazards and safe working practices

Learning outcomes

Learning Outcomes - Knowledge and Understanding

  • Be able to prepare project plans and device documentation
  • Be able to describe the safe working practices using hazardous materials and energy
  • Be able to list the relevant regulations covering hazardous materials and energy.

Learning Outcomes - Intellectual Skills

  • Be able to  carry out  a  product risk analysis
  • Be able to identify the steps to develop a medical device in the framwork of the regulations

Learning Outcomes - Transferable Skills

  • Prepare and use complex project plans
  • Be able to work within the regulatory and developmental framework required by Statutory Bodies
  • Use brainstorming techniques to identfy hazards
  • Evaluate and rank risks and implement a risk management system
  • Be able to timetable and work within a mixed group to a common purpose

Module syllabus

Safety   - Hazards and safe working practices when dealing with

  • chemicals (CoSHH),
  • electrical power

Product Development

  • Design steps, capturing user requirements, ergonomics. verification and validation.
  • Project Planning and Risk Management
  • Quality systems for design and manufacturing. Risk Management. Traceability and surveillance.
  • Medical Device Regulations Europe. Device Classification, Technical File, Annex 1 requirements, Notified body and Competent authority, Audit and the application process,.CE marking.
  • Intellectual property considerations

Teaching methods

Students will be taught over one term using a combination of lectures and study groups. Lecture sessions will be made available on Panaopto for review and supplemented with technologies to promote active engagement during the lecture such as 'learning catalytics'. Study groups will be based on taught content from lectures to reinforce these topics and allow students to test their understanding. 

Lectures:15 hours
Labs:15 hours


●  Item 1:Written report Title:Technical File

Submitted via Turnitin Weighting: 100 %

Module leaders

Dr Warren Macdonald