The objective of this workshop is to learn the first key aspects of the Medical Device Regulations to determine:

• when a product or a software is a medical device and
• what the risk classification of the device is

What will you learn?

By the end of the webinar delegates will be able to:

• Identify if a device / software is a medical device
• Classify a medical device or software as a medical device according to the Medical Device Regulation (EU) risk levels
• Use the regulatory tool: Oxford Global Guidance

Who should attend?

Whether you are a seed stage startup or a mature stage SME, we invite all innovators and entrepreneurs working in the area of medical devices / digital health solutions to attend this webinar!

This webinar will be especially useful for people who are working in the area of medical devices / digital health solutions, including:

• innovators, start ups, SMEs*
• academic researchers
• clinicians
• science students
• research council, research services and tech transfer support

Who is the Speaker?

Rita holds a PhD from the Medical Research Centre (MRC) at King’s College London. Throughout her career, Rita has been part of international multidisciplinary networks and has led large international initiatives in bridging the gaps between different scientific disciplines. Rita played a significant role in setting up and leading the training workstream within ELIXIR, European infrastructure for big data within biological research. She has also experience in working with big pharmaceutical companies. Rita previously worked for the University of Edinburgh and is currently overseeing the development of a data-driven tool to help navigate the medical device regulation at the Natural Interactions Lab based at the University of Oxford. She was involved in the REFORM research on ‘Data-driven healthcare: regulation & regulators’ and closely works with key stakeholders in the regulatory area, such as the MHRA and NHSx. She has given workshops on MDR classification for IEEE and EIT Health and has published on the topic of digital solutions for regulatory navigation.

Who is the Host?

Bucks HSC Ventures is a collaborative programme that provides specialist business support for SMEs and facilitates the accelerated adoption of innovation into the health and social care system using the expertise and networks of our partner organisations: Buckinghamshire New University, the Buckinghamshire Healthcare NHS Trust, the Oxford AHSN, Buckinghamshire Council and Buckinghamshire CCG. The programme is part funded by the European Regional Development Fund (ERDF) Programme.