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Introduction to diagnostic and device regulation in the UK, EU and US
Date: Wednesday 18 November, 4.30-6.30pm
Venue: Online, Zoom link sent to registered attendees
Are you keen to see your approach make a difference, but daunted by the prospect of obtaining regulatory approval? Regulatory expert Dr Kieran Connole from Med Di Dia, a subsidiary of Global Regulatory Services, will cover a range of topics including:
· Approval pathways in the UK/EU and US (including the anticipated impact of Brexit)
· Device and diagnostic classification rules
· Technical documentation
· Clinical evidence
· Examples from oncology, including early detection
The event will take place on Zoom, in two parts with a short break, and will conclude with an open Q&A session. If you are an ACED Member and would like a complementary 1:1 appointment with Dr Connole to discuss your project, please register your interest here or contact Cat Fitzpatrick to find out more.
Posted on 16/11/2020
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