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X-WR-CALDESC:Events for NoBoCap
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DTSTART:20260101T000000
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DTSTART;VALUE=DATE:20260505
DTEND;VALUE=DATE:20260715
DTSTAMP:20260430T161552
CREATED:20260310T130625Z
LAST-MODIFIED:20260310T131018Z
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SUMMARY:Module 2 – Generating Data for Technical Documentation (MDR)
DESCRIPTION:Module 2 – Generating Data for Technical Documentation (MDR) is part of the NoBoCap postgraduate training programme dedicated to strengthening regulatory expertise in the European medical devices sector. \nThis 10-week\, 100% online course focuses on the generation of data required for MDR-compliant technical documentation\, providing participants with practical knowledge relevant for regulatory affairs\, clinical evaluation\, and conformity assessment processes. \nThe module is particularly relevant for professionals working in medical device manufacturing\, regulatory affairs\, notified bodies\, quality management\, as well as SMEs looking to strengthen their teams’ expertise in MDR compliance. \nParticipants who successfully complete the course will receive 5 CPD credits and a postgraduate certificate accredited by the University of Medicine\, Pharmacy\, Science and Technology “G.E. Palade” of Târgu Mureș. \nThe course will begin on 5 May 2026. \nTo register\, create an account on the NoBoCap Portal at www.portal.nobocap.eu\, then navigate to the NoBoCap Courses section and select Module 2 – Generating Data for Technical Documentation (MDR). \nPlaces are limited.
URL:https://nobocap.eu/event/module-2-generating-data-for-technical-documentation-mdr-2/
LOCATION:Online
ATTACH;FMTTYPE=image/png:https://nobocap.eu/wp-content/uploads/2026/03/NoBoCap-Module-2-promo.png
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DTSTART;TZID=UTC:20260507T100000
DTEND;TZID=UTC:20260507T111500
DTSTAMP:20260430T161552
CREATED:20260429T084802Z
LAST-MODIFIED:20260429T084802Z
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SUMMARY:Short Course on EU MDR/IVDR & FDA QMSR
DESCRIPTION:07 May 2026 | 10:00–11:15 | Online\n\n \nNavigating the shifting regulatory landscape: EU MDR/IVDR\, FDA QMSR\, and what it means for your QMS\n \n\nThe regulatory framework for medical devices is undergoing significant transformation on both sides of the Atlantic. The EU MDR and IVDR are being revised to address the risk of supply shortages and ensure continued patient access to critical devices\, while simplifying requirements without compromising safety. At the same time\, the FDA’s new Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 by reference\, a significant step toward harmonizing the US regulatory framework with international standards.\n\n \n\nMeanwhile\, evolving FDA expectations around AI\, cybersecurity\, and submission quality are raising the bar for manufacturers seeking market access. This webinar brings together three expert perspectives to help MedTech companies understand what is changing\, what is driving these changes\, and how to translate new regulatory requirements into practical action for their quality management systems and submission strategies.\n\n \nSession objectives\n \n\n 	Understand the key changes proposed under EU MDR/IVDR and the new FDA QMSR\, and the rationale behind them\n \n 	Learn how evolving FDA expectations around AI and cybersecurity are reshaping documentation and validation requirements\n \n 	Identify common pitfalls in FDA submissions and how to avoid them\n \n 	Translate regulatory changes into concrete implications for your QMS\, including audit and inspection readiness\n\n \nSpeakers\n \n\n 	Sophie Smolders\, StingOrg\n \n 	Ruth Beckers\, Qualix\n \n 	Mieke Janssen\, pRA Consulting\n \n 	Moderated and hosted by Sandra Van Londen\, HQ Vector\n\n \nSession outline\n \n\n 	Welcome and Introduction\n \n 	Presentation 1: EU MDR/IVDR and US FDA QMSR: Background\, rationale and key changes\, Ruth Beckers\, Qualix (15min)\n \n 	Presentation 2: Regulatory changes at the FDA — why good submissions still trigger difficult questions\, Mieke Janssen\, Pra Consulting (15 min)\n \n 	Presentation 3: From regulation to reality\, what these changes mean for your QMS and audit readiness\, Sophie Smolders\, StingOrg (15 min)\n \n 	Moderated panel discussion and Q&A (20 min)\n\n \n\nHow to register\n\n \n\nTo register for the Short Course on EU MDR/IVDR & FDA QMSR:\n\n \n\n 	Create an account on the NoBoCap Portal:\nwww.portal.nobocap.eu\n \n 	Navigate to the NoBoCap Courses section and select\nShort Course on EU MDR/IVDR & FDA QMSR\n\n \n\nPlaces are limited\, and early registration is recommended.
URL:https://nobocap.eu/event/short-course-on-eu-mdr-ivdr-fda-qmsr/
LOCATION:Online
ATTACH;FMTTYPE=image/png:https://nobocap.eu/wp-content/uploads/2026/04/Short-Course-on-EU-MDRIVDR-FDA-QMSR.png
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