Delivery format
In person
Course overview
This introductory course aims to orientate you to the regulatory landscape in which healthcare technologies sit. This will include an introduction to relevant regulatory bodies and their scope, the classification systems applied to healthcare technologies and the standards and processes which are used to evaluate these technologies across their lifecycle. These insights will enable you to understand the demands of regulations upon manufacturers and adopters as they plan their innovation activities. You will also develop the foundation for further training in standards auditing and other professional roles in healthcare quality.
A key component of this course is the focus on Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD). Supported by a range of international guest speakers from policy and industry, the content will reflect the latest trends and regulatory updates in these rapidly evolving areas, not only helping you to understand existing frameworks but also to anticipate changes in regulations as technologies advance. This will provide you with an up-to-date understanding of rapidly evolving regulations in technologies attracting global investment and interest.
Course delivery
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
- Develop and 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
- Create a comprehensive regulatory strategy for a new healthcare technology, including risk assessment, clinical investigation plans, and Post-Market Surveillance (PMS) requirements
Course dates
Monday 26 January - Friday 30 January 2026
On completion of the course you will receive a certificate of completion.
Teaching staff
Anirban Dutta
Associate Professor of Quantitative Biomedicine
Staff profile of Dr Anirban Dutta, Associate Professor of Quantitative Biomedicine, at the Centre for System Modelling and Quantitative Biomedicine, University Â鶹¾«Ñ¡
Alastair Denniston
Chair of Regulatory Science and Innovation
Department of Health Sciences
Alastair Denniston is Professor of Regulatory Science and Innovation at the University Â鶹¾«Ñ¡. He is a leader in the field of Artificial Intelligence (AI) and Digital Health Technologies.
Entry requirements
This course is suitable for recent graduates from healthcare, management, technical or innovation degree programmes. It is also targets mid-career applicants with practical, policy or research roles in healthcare or medtech.
Fees and scholarships
£1516.66
Application process
Please book now via our the last day to book is Monday 5 January but there are limited spaces. If you have any queries, please email mdscpdenquiries@contacts.bham.ac.uk.
The courses have minimum required attendance levels and the University reserves the right to cancel or postpone the course if the minimum required number of delegates has not been achieved for the course.
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