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DTSTART;TZID=Europe/Paris:20261216T090000
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DTSTAMP:20260915T160637
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UID:8671-1797411600-1797438600@www.team-nb.org
SUMMARY:MDR Clinical Training for Manufacturers
DESCRIPTION:Registration Fees & Deadlines\nFor SMEs – Priority for SMEs registration (25 places reserved) until September 25th\n1 person : 450€\n2 persons : 750€ \nFor organisation\n1 person : 900€\n2 persons : 1500€ \nYou can register until November 30th \nREGISTRATION\n\nEvent Summary\nClinical Evaluation Review Training for Manufacturers: lesson learnt and the do’s and don’t’s based on non-conformities examples. \nThis training is directed towards manufacturers/participants who already have experience in creating CER and/or are involved in CE submission. Therefore\, the training will focus more on real cases examples and less on introduction or citing regulations. \nThe topics are presented by MDR experts of designated notified bodies. \nThe content was elaborated by MDR experts of 3 notified bodies\, namely BSI\, CeCertiso\, Dekra. \nThis training is intended for participants who are members of a manufacturer’s clinical team and have experience in creating CERs and/or are involved in CE submission. Therefore\, can you consider this exper-tise for registrations. \n  \n\nPROGRAM\n\n\n\n09.00 – 09.30\n\nWelcome and logistic information\n\n\n\n\n\n\n\n09.30 – 10.45\n\nClinical evaluation routes\n\n\n\n \nÁgnes Horvath\, CE Certiso\n\n\n\n\n\n\n\n10.45 – 11.00\n \nBreak\n\n\n\n\n\n\n\n11.00 – 12.30\n\nHow to build sufficient clinical evidence?\n\n\n\n \nQ&A moderated IVD expert\n\n\n\n\n\n\n\n12:30 – 13:30\n \nBreak\n\n\n\n\n\n\n\n13.30 – 14.45\n \nPost market surveillance and PMCF\n\n\n\n\nBreda Kearney\, BSI\n\n\n\n\n\n\n\n14.45 – 15.00\n \nBreak\n\n\n\n\n\n\n\n15.00 – 16.00\n \nQ&A session\n\n\n\n\n\n\n\n16.00 – 16.30\n \nClosing session\n\n\n\n\n\n\n\n\n\nCancellation policy for training attendance \n\nCancellations must be notified in writing to Team-NB as soon as possible and\, in any case\, no later than 24 hours before the start of the training.\nFor cancellations received less than 24 hours before the start of the training\, no refund will be granted.\nA registered participant may be replaced by another person from the same organisation\, provided that Team-NB is informed before the start of the training and receives the replacement participant’s details.\nNo-shows will be treated as late cancellations and will not be eligible for refund.\nIf Team-NB cancels or postpones a training\, registered participants will be offered either a full refund or transfer to a new date\, where available.
URL:https://www.team-nb.org/event/mdr-clinical-training-for-manufacturers-4/
LOCATION:Remotely
CATEGORIES:Public
ATTACH;FMTTYPE=image/jpeg:https://www.team-nb.org/wp-content/uploads/2026/04/IVDR-TD.jpg
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