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SUMMARY:EU MDR Softward/AL Medical Device CE Marking Workshop
DESCRIPTION:SEHTA\, Psephos Biomedica & Mosaic Surgical would like to invite you to attend our EU MDR Medical Device CE Marking Workshop. \nTHIS EVENT IS NOW FULL. \nWhy attend \nTo sell a medical device in the UK and Europe it must have the CE mark. This process is currently in transition. The new EU Medical Device Regulation (MDR) is in its implementation phase and will be fully effective from May 2020. All medical devices will need to comply with this new legislation. Companies are starting to make the transition and new technologies are going to need to comply with the new regulations. \nThis one-day interactive event will provide an overview of: \nMDR CE Marking Process and the role of a Notified Body and Competent Authority\nMDR Device Classification\nMDR Conformity Assessment routes for class I\, IIa\, IIb and III products\nCompiling Technical Files\, Clinical Evaluation Reports & the Declaration of Conformity\nEudamed\, Labelling and Language translation\nMDR Post Market Surveillance & Vigilance\nOutcomes \nGain an overview of the new EU Medical Device CE Marking Process\nUnderstand the key areas of compliance required\nUnderstand the technical documentation that should be in place for each device\nAn opportunity to discuss next steps\, action plans and areas requiring clarification\nTarget Companies: \nMedical Device companies and Pharma companies with combination products.\nTarget Market: \nC-suite\, executives\, product owners\, medical officers\, regulatory and clinical specialists within a company that need to understand the overall requirements of the new Medical Device Regulation for their medical devices to enable them to place a device on the market and to maintain access after May 2020. All company sizes will find it useful\, but particularly helpful for smaller\, resource constrained organisations \nTo view the programme or to register please click here. \n  \n 
URL:https://staging.medilinkmidlands.com/event/5560/
LOCATION:Hempsons\, 100 Wood Street\, London\, EC2V 7AN\, United Kingdom
ORGANIZER;CN="SEHTA":MAILTO:info@sehta.co.uk
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