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X-WR-CALDESC:Events for NoBoCap
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DTSTART:20250101T000000
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DTSTART;VALUE=DATE:20251107
DTEND;VALUE=DATE:20251213
DTSTAMP:20260430T134146
CREATED:20251029T113848Z
LAST-MODIFIED:20251029T113848Z
UID:14255-1762473600-1765583999@nobocap.eu
SUMMARY:C-level Management Training
DESCRIPTION:MDR/IVDR Implementation and Resource Allocation for C-level Management of MOs is a specialized short course designed for C-level executives. It offers practical training on how to effectively allocate time\, budget\, and other essential resources needed by Market Operators to prepare comprehensive dossiers for Notified Bodies. \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 C-level Management Training. \nHere’s a glimpse of what awaits you in the upcoming sessions: \n• Intro – How to successfully market your MedTech product in today’s highly regulated European landscape📅 07.11.2025The first session provides insights into the regulatory and quality requirements for bringing MedTech products to market under the EU MDR/IVDR*. You will learn how to align your regulatory strategy with your overall business plan (e.g. financial planning and market access strategy). We will guide you through the necessary steps\, timelines\, resources\, and budgets needed for efficient product development—including pre-clinical and clinical testing—quality management system (QMS) setup\, and the creation of high-quality technical documentation for Notified Body assessment. This session also emphasizes that MDR/IVDR compliance requires involvement across the entire organization\, with dedicated roles\, functions\, and competencies. Additional key issues relevant to efficiently and strategically marketing your product in Europe will also be addressed. \n• Which investments are needed to bridge the “regulatory valley of death” in Europe?📅 14.11.2025This webinar focuses on the investments required by your organization to comply with MDR/IVDR*. We will explore the internal and external resources needed—skills\, competencies\, partners\, tools\, and budgets—and how to align them effectively (e.g. test labs\, consultants\, CROs\, and Notified Bodies). You will discover tools that can support the development and maintenance of an electronic QMS and product design throughout the lifecycle. The session also provides an overview of typical budget ranges required to bridge the “regulatory valley of death” and how to align these costs with your business plan. \n• How to select your Notified Body for your innovative MedTech product📅 21.11.2025Learn how to choose the right Notified Body from both practical and strategic perspectives. We will explain the differences between MDR/IVDR codes\, Notified Body capacity\, and the documentation required to submit an application. The session includes practical examples of conformity assessment approaches used by different Notified Bodies\, including timelines and fees. You’ll also gain insight into grouping products efficiently for sampling\, especially in the case of portfolio expansion or product updates. Finally\, we’ll show you how to build and maintain a productive relationship with your Notified Body to support both pre-market and post-market assessments. \n• How to develop and implement an effective Quality Management System and high-quality technical documentation📅 27.11.2025This session highlights the importance of project management in successfully marketing your product under MDR/IVDR*. We’ll share common pitfalls and best practices for developing and maintaining an efficient QMS and a well-structured technical documentation system. SGS\, a Notified Body\, will provide insights from their experience reviewing MDR/IVDR applications and will elaborate on their expectations for submissions from MedTech companies. \n• How to learn from a best-practice case of a start-up that invests at the right time📅 05.11.2025This webinar presents a fictitious case study comparing a start-up that invests at the right time with one that doesn’t. You’ll explore the key elements a start-up should consider when planning its investment strategy. After the session\, participants will receive the business case as a practical exercise to apply to their own projects—highlighting the advantages of timely and strategic investment. \n• Closing session📅 12.12.2025The session offers a chance to summarize the challenges and opportunities discussed in previous sessions. Participants will be encouraged to share their experiences\, lessons learned\, and pitfalls encountered on their regulatory journey. You’ll also have the opportunity to ask specific questions about the steps to market your product under MDR/IVDR*. By the end of the course\, you will have a clear understanding of how to market your product efficiently\, pragmatically\, and strategically in the context of the European regulatory landscape.
URL:https://nobocap.eu/event/c-level-management-training-2/
LOCATION:ZOOM
ATTACH;FMTTYPE=image/png:https://nobocap.eu/wp-content/uploads/2025/10/NoBoCap-short-course-cohort-4.png
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DTSTART;TZID=UTC:20260112T093000
DTEND;TZID=UTC:20260116T120000
DTSTAMP:20260430T134146
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:20260430T134146
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:20260430T134146
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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DTSTART;TZID=UTC:20260507T100000
DTEND;TZID=UTC:20260507T111500
DTSTAMP:20260430T134146
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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