MSc MTRA: Module 3 - Clinical Evaluation of Medical Technologies

Aim

To understand when a clinical investigation is necessary and the regulatory processes involved in clinical evaluation and the alternative routes to demonstrate compliance.

Lectures

Topics covered include:

• Types and designs of clinical studies
• Preclinical requirements
• Clinical evaluation and when to do a study
• Good clinical practice (ISO 14155)
• Clinical trial supplies and labelling
• Post market surveillance studies
• Health economics and device trials

Learning outcomes

Upon completing the course, it is expected that
students will be able to:

• Understand and assess the need for clinical evaluation, including the need to critically evaluate existing literature
• Understand the methodology and conduct of clinical research
• Understand the factors that influence the quality of clinical evaluation

Teaching and learning methods

Lecturers are drawn from a variety of backgrounds but all are recognised experts
currently working in Clinical Research & regulatory affairs relating to medical
technology. There will be a mix of formal lectures, case studies and a dynamic Clinical Trial Simulation Exercise.

Medical Technology Regulatory Affairs MSc

In collaboration with TOPRA, the Cranfield MSc provides for the first time a recognised way for professionals working within healthcare regulatory affairs or related areas to formalise their skills in the field of medical technology. Available on a par t-time basis only, the MSc is designed to be flexible to fit
around your current job and responsibilities. The course is also available at Diploma and Certificate levels. For even greater flexibility, and for professionals with a specific interest, individual modules can be attended as standalone three-day shor t courses.

For more information about our MSc please contact our Enquiries Office
Tel: +44 (0) 1234 758008
Email: enquiries.health@cranfield.ac.uk