Medical Device Certification

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). It has two components: product development for medical devices, & safety, hazards and safe working practices.

Learning outcomes

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 Be able to carry out a product risk analysis Be able to identify the steps to develop a medical device in the framework of the regulations Prepare and use complex project plans Be able to work within the regulatory and developmental framework required by Statutory Bodies Use brainstorming techniques to identify hazards Evaluate and rank risks and implement a risk management system

Module syllabus

Safety - Hazards and safe working practices when dealing with chemicals (CoSHH), lasers, radiation, 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; US(FDA) requirements, predicate devices; 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



●  Written report: System Specification; 15% weighting

●  Written report: Risk Analysis; 15% weighting

●  Written report: Group Technical File; 70% weighting