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UID:18475-1612447200-1612454400@staging.medilinkmidlands.com
SUMMARY:Software UKCA Marking Webinar
DESCRIPTION:The SEHTA and Psephos Software UKCA Marking Webinar takes places on Thursday 4th February 2021.  This 2-hour webinar will help guide you through the changes taking place from 1st January 2021. \nDate: Thursday 4th February 2021 \nTime: 14:00 – 16:00 (GMT) \nWebinar platform: WEBEX \nCost:  Early Bird Rate: Book by 30th November \nSEHTA Members: £115+VAT pp \nSEHTA Non-Members: £130+VAT pp \n\n\n\n\n\n\n\n\n\n\n\n\n\n\nWhy attend? \nThe UKCA (UK Conformity Assessed) Marking is a new UK product marking that will be used for goods being placed on the market in Great Britain (England\, Wales and Scotland).  It covers most goods which previously required the CE Marking\, including medical devices and in vitro diagnostics.  Therefore\, from 1 January 2021\, there will be a number of changes to how companies will be able to place medical devices on the market in Great Britain which will include: \n\nA new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1 January 2021\nFrom 1 January 2021\, all medical devices and in-vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering – 4 months for Class IIIs and Class IIb implantables\, and all active implantable medical devices; 8 months for other Class IIb and all Class IIa devices; and 12 months for Class I devices\nCE Marking will continue to be used and recognised until 30 June 2023\nIf you are a manufacturer based outside the UK and wish to place a device on the UK market\, you will need to establish a UK Responsible Person who will take responsibility for the product in the UK. Further details on the UK Responsible Person\n\nThis webinar will also provide an overview of CE Marking: \n\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\nClinical Investigations\n\nTarget audience:  Manufacturers based outside of the UK wanting to access the UK market\, UK based manufacturers wanting to access the EU market\, Medical Technology Entrepreneurs\, Medical Device Software Developers\, Technology Transfer Officers\, Medical Technology University Researchers\, IVD Developers\, Business Owners\, Executives\, Product Owners\, Regulatory Specialists within a company that need to understand the overall regulatory requirements for their medical devices to enable them to place a device on the market and to maintain access. All company sizes will find it useful. \nClick here to book
URL:https://staging.medilinkmidlands.com/event/software-ukca-marking-webinar/
CATEGORIES:Medilink Partner Event
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DTSTART;TZID=Europe/London:20210218T140000
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UID:18536-1613656800-1613656800@staging.medilinkmidlands.com
SUMMARY:MediWales: LifeScience Academy Special Interest Group
DESCRIPTION:Special Interest Group\nSkills\, recruitment and placements \n18th February 2pm\nThe LifeScience Academy Special Interest Group was created to support and develop our LifeScience Academy activity. The meetings bring together key industry and academic stakeholders to address which areas should be a focus for future events and engagement activity. \nJoin us to discuss: \n\nRecruitment\nHelp with student placements\nSkills gaps\nTraining and professional development\nCollaboration with universities\n\nConnect with other colleagues within the sector for an interactive discussion around these topics. If there are any specific activities or issues you wish to add to the agenda\, please let us know. \nThis is a members only meeting but please get in touch if you are interested to talk to us about getting involved.\nEmail Isabelle to register or find out more \n 
URL:https://staging.medilinkmidlands.com/event/mediwales-lifescience-academy-special-interest-group/
CATEGORIES:Medilink Partner Event
ORGANIZER;CN="Isabelle Ford":MAILTO:isabelle.ford@mediwales.com
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