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X-WR-CALDESC:Events for NoBoCap
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DTSTART:20260101T000000
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BEGIN:VEVENT
DTSTART;TZID=UTC:20260112T093000
DTEND;TZID=UTC:20260116T120000
DTSTAMP:20260430T153340
CREATED:20251216T051125Z
LAST-MODIFIED:20251216T051125Z
UID:14871-1768210200-1768564800@nobocap.eu
SUMMARY:Short Course on Performance Evaluation of AI-based MDSW
DESCRIPTION: First step! Create your account on the NoBoCap Environment at https://portal.nobocap.eu. Then\, go to the NoBoCap Courses section and register for The NoBoCap Short Course on Performance Evaluation of AI-based MDSW. \n  \nWhy This Course Matters: \nIn a fast-evolving world of AI-driven healthcare\, the ability to distinguish a well-evaluated model from a poorly assessed one is important. This hands-on course will not only teach you the fundamentals but will also explore the latest techniques that ensure reliable and fair evaluations of medical AI models. Learn how to navigate common challenges and avoid pitfalls that could compromise your assessments. \nHere’s a glimpse into what awaits you in our upcoming modules: \nModule 1 – Introduction to the Course and the Regulatory Background \nModule 2 – Introduction to AI \nModule 3 – AI Evaluation and Model Performance Metrics \nModule 4 – Introduction to Statistics \nModule 5 – Introduction to Advanced Model Evaluation Topics \nWhat You Will Learn: \n\nSmart Metric Selection: Discover how to choose the right performance metrics and avoid their misuse.\nConfidence Intervals & Sample Sizes: Master statistical essentials for robust model evaluations.\nAI Regulation in Europe: Understand the regulatory framework surrounding AI-based medical devices.\nAdvanced Topics: Dive deep into model bias\, fairness\, explainability\, monitoring\, and robustness evaluation.\n\nWho Should Attend: \nThis course is perfect for notified body assessors\, health technology assessors\, and those from medical AI companies. No prior knowledge is required – just an eagerness to improve your expertise in medical AI performance evaluation.
URL:https://nobocap.eu/event/short-course-on-performance-evaluation-of-ai-based-mdsw/
LOCATION:Online
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BEGIN:VEVENT
DTSTART;TZID=UTC:20260126T080000
DTEND;TZID=UTC:20260128T170000
DTSTAMP:20260430T153340
CREATED:20251208T131419Z
LAST-MODIFIED:20260112T111020Z
UID:14858-1769414400-1769619600@nobocap.eu
SUMMARY:MedTech Winter School: From Design to Clinical Evidence
DESCRIPTION:*Starting January 2026\, registrations for the MedTech Winter School: From Design to Clinical Evidence are accepted only for online participation. \n  \n First step! Create your account on the NoBoCap Environment at https://portal.nobocap.eu. Then\, go to the NoBoCap Courses section and register for MedTech Winter School: From Design to Clinical Evidence. \nA three-day intensive programme organized by Ghent University\, guiding participants through the full MedTech innovation trajectory – from early ideation and systems design to verification & validation\, clinical strategy\, and MDR-compliant evidence generation. The winter school combines lectures\, workshops\, start-up talks\, and practical case-based learning\, following realistic device scenarios across all three days. \nThe course takes place over 3 days during the week of 26 January 2026 (26–28/01)\, CET. \nOnsite participation will be hosted at WATT The Health\, Kliniekstraat 27a\, 9050 Gent\, Belgium.
URL:https://nobocap.eu/event/medtech-winter-school-from-design-to-clinical-evidence/
LOCATION:WATT The Health\, Kliniekstraat 27a\, 9050 Gent\, Belgium\, Kliniekstraat 27a\, 9050 Gent\, Belgia\, Gent\, Gent\, Belgium
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20260505
DTEND;VALUE=DATE:20260715
DTSTAMP:20260430T153340
CREATED:20260310T130625Z
LAST-MODIFIED:20260310T131018Z
UID:14909-1777939200-1784073599@nobocap.eu
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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BEGIN:VEVENT
DTSTART;TZID=UTC:20260507T100000
DTEND;TZID=UTC:20260507T111500
DTSTAMP:20260430T153340
CREATED:20260429T084802Z
LAST-MODIFIED:20260429T084802Z
UID:14953-1778148000-1778152500@nobocap.eu
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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