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BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20260429T090000
DTEND;TZID=Europe/Paris:20260429T170000
DTSTAMP:20260418T152816
CREATED:20260224T073154Z
LAST-MODIFIED:20260401T111817Z
UID:8247-1777453200-1777482000@www.team-nb.org
SUMMARY:MDR Technical Documentation Training for Manufacturers
DESCRIPTION:Registration Fees & Deadlines\n495 € for SMEs – Priority for SMEs registration (25 places reserved) until February 28th\n990 € for organisation \nYou can register until April 10th \nREGISTRATION\n\nEvent Summary\nThe MDCG Position Paper Transition to the MDR and IVDR (MDCG 2022-14) encourages notified bodies to strengthen the communication with manufacturers by means of webinars\, workshops\, targeted feedback and informative sessions.\n\nThe aim of this training is to review the MDR requirements related to Technical Documentation and share notified bodies insights; it is also planned to review the Team-NB Technical Documentation Best Practice document for MDR (version 3—published on April 9th\, 2025 \nThe topics are presented by MDR experts of designated notified bodies.\n\nThe content has been developed and is presented by MDR experts from members of 11 notified bodies\, namely BSI\, CeCert\, CeCertiso\, Dekra\, DNV\, ECM\, GMED\, NSAI\, SGS\, TÜV Rheinland\, TÜV SÜD. \n  \n\nPROGRAM\n\n\n\n09.00 – 09.30\n\nWelcome and logistic information\n\n\n\n\n\n\n\n09.30 – 10.15\n\nStructure of Technical Documentation\n\n\n\n \nAlessandro Nicoletti\, Entercerma\n\n\n\n\nDavid Burke\, NSAI\n\n\n\n \nPurvi Patel\, BSI\n\n\n\n \nSebastian Sowiński\, Ce Cert\n\n\n\n \nVirginie Siloret\, SGS Belgium\n\n\n\n \n\n\n\n\n\n\n\n\n10.15 – 10.30\n \nBreak\n\n\n\n\n\n\n\n10.30 – 12.00\n\nMDR Annex II Sections 1-3\n\n\n\n \nAlexandra Seber\, TÜV SÜD\n\n\n\n \nAnnapoorna Rajan\, Dekra NL\n\n\n\n \nVirginie Siloret\, SGS Belgium\n\n\n\n \nYannick Peron\, BSI\n\n\n\n\n\n\n\n12:00 – 13:15\n \nLunch\n\n\n\n\n\n\n\n13.15 – 14.45\n \nMDR Annex II Sections 4-6 (excluding clinical data)\n\n\n\n\nAmy Chan\, GMED\n\n\n\n\nAndreas Klotz\, TÜV SÜD\n\n\n\n\nChristoph Ziskoven\, TÜV Rheinland\n\n\n\n\nLisa Moloney\, BSI\n\n\n\n\nRegine Großkopf-Lüdemann\, TÜV Rheinland\n\n\n\n\n\n\n\n14.45 – 15.00\n \nBreak\n\n\n\n\n\n\n\n15.00 – 16.30\n \nMDR Annex II Section 6 (clinical data) and An-nex III (post-market surveillance)\n\n\n\n \nÁgnes Horvath\, CE Certiso\n\n\n\n \nAlexey Shiryaev\, DNV\n\n\n\n \nAnna Pietersma\, Dekra NL\n\n\n\n \nBreda Kearney\, BSI\n\n\n\n \nMaria Karakitsou\, SGS Belgium\n\n\n\n \nNunung Nur Rahmah\, Dekra NL\n\n\n\n\n\n\n\n16.30 – 17.00\n \nClosing session
URL:https://www.team-nb.org/event/mdr-technical-documentation-training-for-manufacturers/
LOCATION:Remotely
CATEGORIES:Public
ATTACH;FMTTYPE=image/jpeg:https://www.team-nb.org/wp-content/uploads/2026/02/MDR-TECHNICAL-TRAINING.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20260528T090000
DTEND;TZID=Europe/Paris:20260528T163000
DTSTAMP:20260418T152816
CREATED:20260308T165211Z
LAST-MODIFIED:20260401T110610Z
UID:8289-1779958800-1779985800@www.team-nb.org
SUMMARY:MDR Clinical Training for Manufacturers
DESCRIPTION:Registration Fees & Deadlines\n600 € for SMEs – Priority for SMEs registration (25 places reserved) until March 27th\n1200 € for organisation \nYou can register until April 28th \n\nEvent Summary\nClinical Evaluation Review Training for Manufacturers: lesson learnt and the do’s and don’t’s based on non-conformities examples.\n\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.\n\nThe content was elaborated by MDR experts of 3 notified bodies\, namely BSI\, CeCertiso\, Dekra.\n\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 \nNunung Nur Rahmah\, Dekra NL\n\n\n\n\n\n\n\n12:30 – 13:30\n \nLunch\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\n\n\n\n\n\nREGISTRATION
URL:https://www.team-nb.org/event/mdr-clinical-training-for-manufacturers-3/
LOCATION:Remotely
CATEGORIES:Public
ATTACH;FMTTYPE=image/jpeg:https://www.team-nb.org/wp-content/uploads/2026/04/MDR-CLINICAL-TRAINING.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Paris:20260702T090000
DTEND;TZID=Europe/Paris:20260702T170000
DTSTAMP:20260418T152816
CREATED:20260401T113611Z
LAST-MODIFIED:20260401T114116Z
UID:8366-1782982800-1783011600@www.team-nb.org
SUMMARY:IVDR Technical Documentation Training for Manufacturers
DESCRIPTION:Registration Fees & Deadlines\n600 € for SMEs – Priority for SMEs registration (25 places reserved) until April 24th\n1200 € for organisation \nYou can register until June 1st \nREGISTRATION\n\nEvent Summary\nThe MDCG Position Paper Transition to the MDR and IVDR (MDCG 2022-14) encourages notified bodies to strengthen the communication with manufacturers by means of webinars\, workshops\, targeted feedback and informative sessions\n\nThe aim of this training is to review the IVDR requirements related to Technical Documentation and share notified bodies insights; \n; it is also planned to review the Team NB Technical Documentation Best Practice document for IVDR (published on March 1st 2023).\n\nThe topics are presented by IVD experts of IVDR designated notified bodies. The content was elaborated by IVD experts of 7 notified bodies\, namely BSI\, Dekra B.V.\, Dekra GmbH\, GMED\, NSAI\, TÜV Rheinland LGA and TÜV SÜD. \n  \n\nPROGRAM\n\n\n\n09.00 – 09.30\n\nWelcome of participants\n\n\n\n\n\n\n\n09.30 – 10.45\n\nThe (pre) application phase\n\n\n\n \nQ&A moderated IVD expert\n\n\n\n\n\n\n\n10.45 – 11.00\n \nBreak\n\n\n\n\n\n\n\n11.00 – 12.15\n\nDirective to Regulation data\n\n\n\n \nQ&A moderated IVD expert\n\n\n\n\n\n\n\n12:15 – 13:30\n \nLunch\n\n\n\n\n\n\n\n13.30 – 14.45\n \nPerformance Evaluation\n\n\n\n\nQ&A moderated IVD expert\n\n\n\n\n\n\n\n14.45 – 15.00\n \nBreak\n\n\n\n\n\n\n\n15.00 – 16.15\n \nPost market surveillance and PMCF\n\n\n\n\nQ&A moderated IVD expert\n\n\n\n\n\n\n\n16.15 – 17.00\n \nClosing session\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n 
URL:https://www.team-nb.org/event/ivdr-technical-documentation-training-for-manufacturers/
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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