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 2 : Quality Assurance, Risk Management and the Software Development Lifecycle
This webinar explains the quality and risk management processes that underpin successful medical device development.
Topics include:
- Regulatory affairs versus quality assurance
- Building a quality-focused culture
- Introduction to ISO 13485 Quality Management Systems
- Key standards for software and AI medical devices, including IEC 62304, IEC 62366 and ISO 14971
- Risk management principles
- Software testing and validation
- Key differences between traditional software and AI systems
- Speaker
Lucy Rogers, Quality Assurance & Cyber Security Consultant, Hardian Health
- Booking
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