Quality Assurance for Healthcare Technologies University of Birmingham

Overview

Participants will gain a foundational understanding of key regulatory bodies, classification systems, and the standards and processes used to evaluate technologies throughout their lifecycle. The Quality Assurance for Healthcare Technologies course at University of Birmingham highlights the regulatory demands placed on both manufacturers and adopters, helping participants align innovation activities with compliance requirements.

A central focus of the course is the regulation of Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD). With contributions from guest speakers across policy and industry, the course content reflects the latest developments and global trends in these rapidly evolving areas. Participants will not only learn about current frameworks but also gain insights into how they may evolve as technologies advance.

On completion of the course you will be able to:

• Demonstrate understanding of the jurisdiction and function of regulatory bodies, their public databases and relevant standards for different healthcare technologies.

• Evaluate intended use statements for healthcare technologies to propose and justify medical device status and classification.

• Critically evaluate a Technical File and Quality Management System (QMS) in line with ISO 13485 standards and other relevant regulations.

• Evaluate the alignment of evidence with claims made about healthcare technology functionality.