Quality Assurance for Healthcare Technologies 30 credits

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.

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

Course dates for 2027 are TBC. This course typically runs in January. 

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

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.

Home fees (Microcredential): £1,875

International fees (Microcredential): £5,250

Non-credit fee: £1575

You can 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.

See how the University of Birmingham uses your data, view the Event attendee privacy notice.

Why choose a Postgraduate Microcredential short course?

• Microcredentials offer the perfect opportunity to boost your CV without the commitment of a full degree
• Usually taken from existing modules within a Masters, they can be used as standalone credentials with some also counting as academic credits at postgraduate level
• Add a postgraduate level qualification to your CV
• Develop the specialist skills you need for your career goals
• Alumni status with the University of Birmingham
• Learners will have the same access to our student support and campus facilities as our students on full degree programmes.

Please note the deadline for submitting an application:

• Applicants eligible for Home fees are to apply a minimum of 6 weeks before the module start date.
• Applicants eligible for Overseas fees are to apply a minimum of 3 months before the module start date.

Please note that once registered for the microcredential you cannot swap for the non-credit short course version.

Non-credit short course

The microcredential and the non-credit short course follow the same course structure, the difference between them both is with the non-credit short course you do not take the assessment at the end therefore you will not receive credits but will receive a certificate of completion, this certificate cannot be converted to credits.

Please note if you apply for the non-credit short course, you cannot swap to the microcredential version once registered.

Places on the non-credit short course are limited so please enquire before if spaces are available.

See how the University of Birmingham uses your data, view the Event attendee privacy notice.