HDRUK Event
is a specialist consultancy helping organisations navigate the development, regulation, and adoption of software and AI-based medical devices. Their team combines expertise in healthcare, clinical evaluation, quality management, regulatory affairs, and product development, supporting innovators from concept through to market access. Whether you’re developing a new health technology, exploring the medical device landscape, or preparing for regulatory approval, Hardian Health provides practical guidance grounded in real-world experience.
Workshop Series Overview: The global medical device market continues to grow rapidly, creating exciting opportunities for innovators developing digital health technologies and AI-enabled solutions. However, bringing a medical device to market requires an understanding of regulation, quality management, clinical evidence, and risk management. This three-part webinar series, delivered by experts from Hardian Health, provides a practical introduction to the key considerations involved in developing Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD). Through real-world examples and case studies, participants will gain insights into the regulatory landscape and the steps required to develop safe, effective, and compliant health technologies.
Who Should Attend?
This webinar series is designed for anyone interested in understanding the development and regulation of medical technologies, particularly software and AI-enabled health solutions.
The sessions will be especially valuable for:
- Researchers developing digital health technologies
- SMEs and start-ups working in health technology
- Entrepreneurs exploring medical device innovation
- NHS, health and care professionals interested in healthcare technology
- Innovators developing AI-based healthcare solutions
- Individuals considering a career in the medical technology sector
No prior regulatory expertise is required.
Webinar 1 : Introduction to Medical Device Regulation for Software and AI Technologies
This introductory session explores how software and AI products are regulated as medical devices and what innovators need to consider from the earliest stages of development.
Topics include:
- An introduction to UK, EU and international medical device regulation
- Understanding Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD)
- Defining your product’s intended use and value proposition
- Qualification and classification of software and AI medical devices
- Regulatory pathways, timelines, and key considerations
- Borderline cases and real-world examples
- Speaker
Dr Felicity Lock, Senior Clinical Associate, Hardian Health
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