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SUMMARY:In Vitro Diagnostic (IVD) New IVDR CE Marking Workshop
DESCRIPTION:This seminar will provide you insights into the key regulatory changes of the IVDR\, to help you to prepare your organisation and your devices for IVDR compliance. \nCost: SEHTA members fee: £240 + VAT / Non-Members: £280 + VAT per delegate \nNot a member of SEHTA? It’s free to join – just click here \nThe Invitro Diagnostic Regulations are in transition and companies need to understand and prepare for these significant changes. Attendees will gain an understanding of: \n-The new IVD regulations (EU 2017/746)\, Device Classification and Key Time Lines\n-Significant differences between the current directive (98/79/EC) and the new IVD Regulations\n-The role and status of Notified Bodies\n-Outline of the Technical Documentation including Labelling and EUDAMED\n-Outline of the Quality System requirements\n-Outline of the Performance requirements/Clinical evidence\n-Outline of Post Market Surveillance requirements \nFor further information and to register\, please click here.
URL:https://staging.medilinkmidlands.com/event/in-vitro-diagnostic-ivd-new-ivdr-ce-marking-workshop/
LOCATION:Hempsons\, 100 Wood Street\, London\, EC2V 7AN\, United Kingdom
CATEGORIES:Medilink Partner Event
ORGANIZER;CN="SEHTA":MAILTO:info@sehta.co.uk
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