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Medical device regulations – Software as a medical device

Organiser: Bucks HSC Ventures

Venue: Online via zoom

Address:

Date & Time: 14 Jul 2020 - 10:30 am-12:00 pm

This event is for businesses and residents located in England due to eligibility rules on support.

This Bucks Health and Social Care Ventures programme workshop is fully funded and free to access . We have a number of workshops planned, if you would like to find out more then please check our website for further details of the support you can receive.

Are you developing a software for the health sector?
Are you unsure if you need to adhere to the Medical Device Regulations?
Or what the risk classification of your software is according to the Medical Device Regulations?
Then this workshop is for you.

The objective of this workshop is to understand when software is a medical device according to the medical device regulations and the latest guidance documents. We will also discuss different risk classification for software as a medical device.

Who should attend?

People who are working in the area of medical devices/digital health solutions, including:

academic researchers
clinicians
science students
innovators
start-ups
SMEs
research council
research services and tech transfer support.
What will I learn?

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

Identify if a software is a medical device
Classify a software according to the Medical Device Regulation (EU) risk levels
Hands on experience in using the regulatory tool: Oxford Global Guidance
Rita Hendricusdottir

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 work stream 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.

Please note that the workshops are funded by European Regional Development Fund (ERDF) and are available to eligible SME applicants as part of the Bucks HSC Ventures programme. Sign up to these events to express your interest for an ERDF funded place and a member of our team will follow up with you. A maximum of one ERDF funded ticket per business is available. Please note that the event is for SMEs based in the UK and we will limit tickets to non-businesses or people outside of the UK.

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