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X-WR-CALDESC:Events for NoBoCap
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DTSTART;VALUE=DATE:20260505
DTEND;VALUE=DATE:20260715
DTSTAMP:20260903T192827
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:20260903T192827
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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BEGIN:VEVENT
DTSTART;TZID=Europe/Bucharest:20260521T140000
DTEND;TZID=Europe/Bucharest:20260521T150000
DTSTAMP:20260903T192827
CREATED:20260518T140124Z
LAST-MODIFIED:20260518T141523Z
UID:14960-1779372000-1779375600@nobocap.eu
SUMMARY:Online Workshop: From Innovation to CE-Marking: Smart NoBoCap E-Tools for HealthTech\, MedTech and Digital Health SMEs
DESCRIPTION:We are pleased to invite you to the NoBoCap & IRHIS Online Workshop: From Innovation to CE-Marking: Smart NoBoCap E-Tools for HealthTech\, MedTech and Digital Health SMEs \n  \n\n\n\nThis workshop will present practical NoBoCap e-tools designed to support HealthTech\, MedTech and Digital Health SMEs/ Startups in understanding MDR/IVDR regulatory requirements and preparing for the CE-marking journey. \n  \n\n\n\nDate: 21 May 2026 \n\n\n\nTime: 13:00-14:00 CET \n\n\n\n🔗 Register: HERE \n\n\n\n(Your registration details will be used for sharing webinar materials.) \n  \n\n\n\nThe session will include: \n\n\n\n• introduction to NoBoCap E-Tools by Luminita Arhip\, Altfactor; \n• NoBoCap E-Guided MDR/IVDR Learning – NB Codes\, led by Heikki Pitkänen\, Lean Entries\, with Altfactor and IRHIS SME Vilimed. Real SME case: how to use the e-tool in practice; \n• demonstration of NoBoCap Matchmaking Innovation – Notified Body\, presented by Luminita Arhip\, Altfactor\, together with IRHIS SME Vilimed; \n• announcement of upcoming NoBoCap trainings by Camelia Bulat\, ROHEALTH.
URL:https://nobocap.eu/event/online-workshop-from-innovation-to-ce-marking-smart-nobocap-e-tools-for-healthtech-medtech-and-digital-health-smes/
LOCATION:ZOOM
ATTACH;FMTTYPE=image/jpeg:https://nobocap.eu/wp-content/uploads/2026/05/NoBoCap-Workshop-Agenda-2026-05-21-1.jpg
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BEGIN:VEVENT
DTSTART;TZID=UTC:20260925T080000
DTEND;TZID=UTC:20261016T170000
DTSTAMP:20260903T192827
CREATED:20260728T121904Z
LAST-MODIFIED:20260728T121904Z
UID:14999-1790323200-1792170000@nobocap.eu
SUMMARY:Save the Date: MDR/IVDR Implementation and Resource Allocation for C-level Management of Market Operators
DESCRIPTION:Save the Date: MDR/IVDR Implementation and Resource Allocation for C-level Management of Market Operators\n📅 Course dates:\n25 September • 2 October • 6 October • 9 October • 13 October • 16 October 2026 \nThe MDR/IVDR Implementation and Resource Allocation for C-level Management of Market Operators is a specialised short course designed for C-level executives of Market Operators. \nThe course provides practical guidance on how to effectively allocate time\, budget\, and organisational resources required to prepare high-quality technical documentation and successfully navigate the conformity assessment process with Notified Bodies under the MDR and IVDR frameworks. \nSave the dates! More information and registration details will be available soon. \nGet ready by creating your account on the NoBoCap Environment:\n👉 https://portal.nobocap.eu \nOnce registration opens\, you will be able to enrol through the NoBoCap Courses section of the platform.
URL:https://nobocap.eu/event/save-the-date-mdr-ivdr-implementation-and-resource-allocation-for-c-level-management-of-market-operators/
LOCATION:Online
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20261019T080000
DTEND;TZID=UTC:20261021T170000
DTSTAMP:20260903T192827
CREATED:20260728T105610Z
LAST-MODIFIED:20260728T105644Z
UID:14994-1792396800-1792602000@nobocap.eu
SUMMARY:NoBoCap Safe MedTech Challenge at BEHEALTH 2026
DESCRIPTION:NoBoCap Safe MedTech Challenge at BEHEALTH 2026\n📅 19–21 October 2026\n📍 Bucharest\, Romania \nThe NoBoCap Safe MedTech Challenge is coming to BEHEALTH 2026\, bringing together students\, researchers\, startups\, healthcare professionals\, engineers\, entrepreneurs\, and innovators to tackle real-world challenges in the medical technology sector. \nOver three days\, multidisciplinary teams will collaborate to develop innovative\, safe\, and regulatory-ready MedTech solutions\, supported by experienced mentors and evaluated by an international jury. Participants will have the opportunity to connect with manufacturers\, notified bodies\, investors\, policymakers\, and healthcare experts from across Europe while gaining hands-on experience in innovation and medical device regulation. \nWhether you have an innovative idea or simply want to contribute your skills to a team\, this hackathon is your opportunity to make an impact in the future of healthcare. \nWhy participate? \n\nCollaborate in multidisciplinary teams\nReceive mentorship from international experts\nDevelop solutions for real MedTech challenges\nNetwork with the European healthcare innovation ecosystem\nCompete for awards and recognition\n\nRegistration is now open! \nJoin us in Bucharest and become part of the next generation of safe and innovative medical technologies.
URL:https://nobocap.eu/event/nobocap-safe-medtech-challenge-at-behealth-2026/
LOCATION:Romanian Banking Institute (IBR)\, 3 Negru Vodă Street\, Sector 3\, 030774 Bucharest\, Romania\, 3 Negru Vodă Street\, Bucharest\, 030774\, Romania
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20261019T080000
DTEND;TZID=UTC:20261021T170000
DTSTAMP:20260903T192827
CREATED:20260813T111511Z
LAST-MODIFIED:20260813T111511Z
UID:15002-1792396800-1792602000@nobocap.eu
SUMMARY:Performance Evaluation of AI-based Medical Device Software (MDSW)
DESCRIPTION:Performance Evaluation of AI-based Medical Device Software (MDSW)\n19–21 October 2026 | Bucharest\, Romania | On-site training \nDuring BEHEALTH 2026\, NoBoCap will organise the on-site training course “Performance Evaluation of AI-based Medical Device Software (MDSW)”\, taking place in Bucharest from 19 to 21 October 2026. \nThe three-day training will focus on the performance evaluation of AI-based Medical Device Software\, providing participants with practical and regulatory perspectives relevant to the development\, assessment and evaluation of AI-enabled medical technologies. \nThe course is particularly relevant for: \n\nEconomic operators in the medical device sector;\nNotified Body assessors;\nHealth Technology Assessment professionals;\nRepresentatives of companies developing or working with medical AI solutions;\nOther professionals interested in the practical and regulatory aspects of AI-based medical technologies.\n\nCertificates\nParticipants will have the opportunity to obtain: \n\nCertificate of Completion\, based on an assessed test;\nCertificate of Participation.\n\nParticipation in the course is free of charge. As this is the final free training course organised within the NoBoCap project\, places are limited\, and early registration is strongly encouraged. \nHow to register\nStep 1: Create an account on the NoBoCap Platform:\nhttps://portal.nobocap.eu \nStep 2: Access the NoBoCap Courses section and register for:\nPerformance Evaluation of AI-based Medical Device Software (MDSW) \nhttps://portal.nobocap.eu/register-course/11 \nJoin us in Bucharest for three days of specialised training on the evaluation of AI-based Medical Device Software.
URL:https://nobocap.eu/event/performance-evaluation-of-ai-based-medical-device-software-mdsw/
LOCATION:Romanian Banking Institute (IBR)\, 3 Negru Vodă Street\, Sector 3\, 030774 Bucharest\, Romania\, 3 Negru Vodă Street\, Bucharest\, 030774\, Romania
ATTACH;FMTTYPE=image/png:https://nobocap.eu/wp-content/uploads/2026/08/260722_NoBoCap_Promo-2-5.png
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