Course Details in 2025/26 Session

Module Title	LM Improving Quality and Patient Safety in novel medical technology use
School	Institute of Clinical Sciences
Department	Institute of Clinical Sciences
Module Code	02 37156
Module Lead	Matthew Campbell-Hill
Level	Masters Level
Credits	20
Semester	Semester 1
Pre-requisites
Co-requisites
Restrictions	None
Exclusions
Description	This module covers the application of quality control systems, processes and regulations used when assessing and using novel medical technologies, whether in early practice or during research, and identify possible areas for improvement. brbrMedical technology safety is a fundamental requirement of healthcare regulation and practices during development evaluation are particularly stringent. Through the use of examples from recent publications from the MTEP programme and wider regulatory research literature, the safety issues and requirements of the western medical regulation are explored. Students work individually to review multiple individual technologies that have been assessed and identify the relevant factors that influenced the safety protocols and quality by design outcomes. Students present on specific areas of interest within quality and/or safety requirements and engagement practices required. Students also present a walk-through of the regulatory process for two devices that are already on the market, showing a deep understanding of the regulatory pathway for medical devices. The findings are presented in oral presentations and written reports, and feedback is given that students are able to refine their approaches and develop their written reports.
Learning Outcomes	By the end of the module students should be able to: Describe how new medical technologies are regulated and the relevant regulatory bodies Describe how requirements for quality drive innovation in medical device regulation Evaluate the relative merits of alternative approaches for regulation in emerging technologies such as digital/software as a medical device/machine learning, enabling quality and safety in a fast evolving technology landscape; and Demonstrate an awareness of the different approaches internationally to regulation and quality
Assessment	37156-01 : Overall Module Mark : Mixed (100%)
Assessment Methods & Exceptions	Assessment: 50% Individual presentations 50% individual written report, 2000 words Reassessment: 100% resubmission of written report, 2000 words
Other
Reading List