AI in Healthcare: A Practical Guide to Medical Device Development Webinar Series

About Hardian Health

Hardian Health 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.

Learning Objectives

By the end of this webinar series, participants will be able to:

Understand what constitutes a Software as a Medical Device (SaMD) and an AI as a Medical Device (AIaMD).
Explain the key regulatory requirements for medical devices in the UK and internationally.
Develop a clear statement of intended use and understand its importance in regulatory classification.
Identify how software and AI medical devices are classified and regulated.
Recognise the clinical evidence required to demonstrate safety, performance, and effectiveness.
Understand the role of quality management systems, risk management, and software lifecycle processes in medical device development.
Gain confidence in navigating the medical technology landscape, from early innovation through to market readiness.

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 Details

Webinar 1

Introduction to Medical Device Regulation for Software and AI Technologies
12 November | 15:00-17:00

Speaker: Dr Felicity Lock, Senior Clinical Associate, Hardian Health

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

Webinar 2

Quality Assurance, Risk Management and the Software Development Lifecycle
1 December | 15:00-16:00

Speaker: Lucy Rogers, Quality Assurance & Cyber Security Consultant, Hardian Health

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

Webinar 3

Clinical Evaluation of AI Medical Devices
3 December | 15:00-16:00

Speaker: Dr Rayan Taher, Clinical Associate, Hardian Health

This session introduces the evidence needed to demonstrate that an AI-enabled medical device is safe, effective, and clinically valuable.

Topics include:

Understanding clinical evidence requirements
Scientific, analytical, and clinical validation
Evidence generation throughout the product lifecycle
Pre-market and post-market clinical documentation
Literature reviews and evidence synthesis
Practical examples from digital health and AI technologies

What Previous Attendees Say

“A comprehensive and well-paced workshop that filled key gaps in my understanding. The knowledgeable speakers brought real expertise and made complex topics around the development of medical technologies accessible.”

Speaker bios:

Felicity is a Senior Clinical Associate at Hardian Health, having trained in medicine and biomedical engineering. She worked as an NHS doctor for several years before leaving clinical medicine to combine her interests, and now focuses on product, regulatory and clinical evaluation strategy for SaMD and AIaMD.
Rayan is a Clinical Associate at Hardian Health, and a PhD graduate, focused on the safety of digital mental health interventions. She has experience across academia, the NHS, and the healthtech industry, bringing a well-rounded perspective to the evolving intersection of technology and healthcare.
Lucy is a Quality Assurance & Cyber Security Consultant at Hardian Health. She has experience in EU MDR technical file preparation, ISO 13485 implementation and maintenance, FDA pre-submissions, UAE regulatory support, and Information Security/Cyber Security expertise.

Funding Acknowledgement

This training is funded by Northern Health Futures (NortHFutures), a collaborative digital health hub that addresses unmet health and care needs of populations in the North East and North Cumbria (NENC) region of the UK.

Hardian Health links