Delivery format
In person
Course overview
This introductory CPD course provides a comprehensive orientation to the regulatory landscape surrounding healthcare technologies. 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 course 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.
Course delivery
Day 1 – Foundations of Regulation
The course opens with an introduction to the role of regulation in health technologies, covering legal frameworks, standards, and guidance. A hands-on session introducing regulatory database searching follows an exploration of the full innovation pipeline and the roles of different regulatory gatekeepers who act across it.
Day 2 – Risk Management
This day focuses on hardware, software, and complex devices containing both elements. Attendees engage in drafting intended use statements and the analysis of associated risks. The afternoon introduces human factors in device design and model-based systems engineering.
Day 3 – AI and Software Regulation
Participants delve into software lifecycle management, design change control, and cybersecurity considerations. The course then explores the regulatory implications of AI technologies in healthcare, including generative AI as a medical device and the EU AI Act.
Day 4 – Regulatory Strategy and its Implementation
The fourth day addresses the clinical development lifecycle, including requirements for post-market surveillance. Attendees will hear directly from experts about what it takes to achieve regulatory clearance, then shift to developing regulatory strategies that addresses both developers’ goals and regulatory requirements.
Day 5 – Wider Context and Horizon Scanning
The final day broadens the lens to focus on the business context of AI and international guest lecturers compare and contrast different regulatory jurisdictions. Regulatory experts share their perspectives on emerging challenges such as adaptive models, predetermined change control plans, and in-house development.
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.
Course dates
26th - 30th January 2026.
On completion of the course you will receive a certificate of completion.
Guest lecturers
Prof Bilal Mateen, Chief AI Officer, PATH
Prof Peter Bannister, Managing Director, Romilly Life Sciences
Hannah Richardson, Senior Manager, Compliance & Regulatory, Microsoft Research – Health Futures
Prof Paul Wicks, Wicks Digital Health
Johan Ordish, Associate professor, University of Birmingham
Dr Hugh Harvey, Managing Director, Hardian Health
Michael Pogose, Director - Quality Assurance and Regulatory Affairs, Hardian Health
Dr Ankeet Tanna, Clinical Consultant, Hardian Health
Dr Felicity Lock, Clinical Associate, Hardian Health
Dr Stephen Duffield, Associate Director of Real-world Evidence Methods, National Institute for Health and Care Excellence
Dr Basil Bekdash (Paediatric Surgeon); Clinical Safety Officer, Sheffield Children’s NHS Foundation Trust
Charlie Stephens, Head of Commercial for Innovation, Research, Life Sciences and Strategy (IRLSS) and MedTech, NHS England
Akash Dhade, Associate Manager- Regulatory Services, Venture Center
Duglas Rodrigues-Calderon, Global Head of LATAM Regulatory Policy, Global Regulatory Policy & Intelligence, Roche Diagnostics
Surbhi Gupta, Regulatory Affairs Lead (Software Medical Devices), NHS England
Teaching staff
Dr Anirban Dutta
Associate Professor of Quantitative Biomedicine
Associate Professor of Quantitative Biomedicine and Strategy Lead for Industry and Knowledge Exchange at SMQB
Professor Alastair Denniston
Chair of Regulatory Science and Innovation
Professor of Regulatory Science and Innovation and Honorary Consultant Ophthalmologist at University Hospitals Birmingham NHSFT
Professor Muireann Quigley
Professor of Law, Medicine, and Technology
Professor of Law, Medicine, and Technology whose research focuses on bodies, biomaterials and biotechnologies
Dr Aditya (Adi) Kale
Clinical Research Fellow
Dr Kale is undertaking doctoral research in the evaluation and regulation of AI as a medical device.
Dr Jeffry Hogg
Honorary Clinical Research Associate
Clinician scientist leading responsible Artificial Intelligence (AI) innovation in healthcare through practice, education and research.
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 online shop the last day to book is Monday 5 January but there are limited spaces. If you have any queries, please email cmhcpdenquiries@contacts.bham.ac.uk.
You can also email clinicalaimsc@contacts.bhm.ac.uk should you have any questions about this course.
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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