Medical Device Regulations --- Interactive Workshop
St Andrews Innovation and the MacKenzie Institute are pleased to co-host an interactive online workshop led by RegMetrics, focused on navigating the regulatory landscape for medical devices and digital health solutions.
This hands-on session is ideal for academic researchers, clinicians and professional services staff working in or supporting medical device and digital health innovation. Whether you're in the early stages of development or preparing a funding proposal, this workshop will help you understand:
Whether your product qualifies as a medical device
How to classify a medical device under EU Medical Device Regulation (MDR)
Key regulatory requirements your device must meet
How to incorporate regulatory insights into funding applications
You'll also receive guided access to RegMetrics, a compliance platform used by top institutions like the University of Oxford, UCL and the University of Birmingham. You will gain practical experience using RegMetrics, which simplifies the complex medical device regulatory pathway with step-by-step guidance and official documentation references.
About the Hosts:
St Andrews Innovation is the University of St Andrews' dedicated hub for research commercialisation, partnerships and enterprise support. It connects cutting-edge research with real-world applications, supporting academic entrepreneurship and innovation.
The MacKenzie Institute for Early Diagnosis hope to drive forward high-quality leading research in early diagnosis through inter- and multi-disciplinary collaborations within the University's School's and with external collaborators. It's mission is to accelerate the translation of diagnostic innovation from bench to bedside, with a particular focus on improving early detection and outcomes.
About the Speaker:
Dr. Rita Hendricusdottir, CEO of RegMetrics, holds a PhD in Neuroscience from King's College London and is dedicated to bridging the gap between engineering and regulatory science to help bring innovative medical technologies to patients more efficiently.
Access to RegMetrics
Attendees will receive access to RegMetrics starting the day before the workshop until the day after. Instructions on how to register and unlock premium features will be sent 2 days in advance.
Don't miss this opportunity to demystify medical device regulations and strengthen your research and innovation journey.