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X-ORIGINAL-URL:https://nobocap.eu
X-WR-CALDESC:Events for NoBoCap
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TZID:UTC
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TZOFFSETFROM:+0000
TZOFFSETTO:+0000
TZNAME:UTC
DTSTART:20240101T000000
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BEGIN:VEVENT
DTSTART;TZID=UTC:20240924T130000
DTEND;TZID=UTC:20240925T170000
DTSTAMP:20260430T134146
CREATED:20240628T075226Z
LAST-MODIFIED:20240822T060454Z
UID:13090-1727182800-1727283600@nobocap.eu
SUMMARY:NoBoCap Community Summit
DESCRIPTION:Summit by NoBoCap Community unlocking the MDR/IVDR regulation for innovators in Europe. \nThe Summit will take place on the 24th and 25th of September 2024\, two days of in-person high-level dialogues and sessions\, in Brussels. \nHear the speakers discuss building your knowledge about MDR\IVDR requirements\, gain insights from EC Representatives on the evolving EU regulatory environment\, and participate in workshops and panel discussions. \nJoin NoBoCap Community Summit to stay ahead in the evolving regulatory landscape and ensure your innovations comply with MDR/IVDR requirements. \nRegistration is for NoBoCap Community Members and partners and for Innovation Hubs/Clusters\, Know-How Partners and Notified bodies interested in the Activities of the Community to unlock MDR/IVDR for Innovation. \n\nMore information you will find on our website!
URL:https://nobocap.eu/event/nobocap-community-summit/
LOCATION:Brussel\, Brussel\, Belgium
ATTACH;FMTTYPE=image/png:https://nobocap.eu/wp-content/uploads/2024/06/NoBoCap-Summit-Program-e1719564099227.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20241022
DTEND;VALUE=DATE:20241026
DTSTAMP:20260430T134146
CREATED:20240925T082950Z
LAST-MODIFIED:20240925T082950Z
UID:13401-1729555200-1729900799@nobocap.eu
SUMMARY:BEHEALTH & DIGITAL 2024 - Hybrid International Event in Healthcare
DESCRIPTION:BeHEALTH brings together companies\, organizations\, universities\, and public entities\, creating the ideal environment for international partnerships\, and ultimately enhancing economic competitiveness in the healthcare sector. \nThis year\, the ROHEALTH Cluster is organizing the 7th edition of the BeHealth event in collaboration with Babeș-Bolyai University of Cluj-Napoca\, the Center Region Support Association\, the Transilvania IT Cluster\, and the Romanian Society of Medical Informatics. The event\, titled BeHealth & Digital – Hybrid International Event in Healthcare\, will take place from October 22-25\, 2024\, in Cluj-Napoca\, Romania and online. \nAgain\, we have dedicated a panel to the NoBoCap project as part of this event. This year’s panel\, Navigating the MDR and IVDR Regulatory Framework: Compliance and Best Practices\, is scheduled for October 22\, from 15:30 to 17:00 EEST\, on the first day of the event. \nDon’t miss this chance to spark innovation and help shape tomorrow’s solutions! \nJoin us and stay at the forefront of the ever-evolving healthcare landscape! \n 
URL:https://nobocap.eu/event/behealth-digital-2024-hybrid-international-event-in-healthcare/
LOCATION:Mihail Kogălniceanu Street\, no 5\, Cluj-Napoca 400000\, Romania\, Mihail Kogalniceanu Street\, no 5\, Cluj-Napoca\, Cluj-Napoca\, 400000\, Romania
ATTACH;FMTTYPE=image/png:https://nobocap.eu/wp-content/uploads/2024/09/BEHEALTH-event-promo-2024.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20241108
DTEND;VALUE=DATE:20241214
DTSTAMP:20260430T134146
CREATED:20240924T093843Z
LAST-MODIFIED:20240924T093843Z
UID:13399-1731024000-1734134399@nobocap.eu
SUMMARY:Short Course on Training for C-level Management (2)
DESCRIPTION:Join us for an exclusive Short Course designed for C-level management professionals! \nHere’s a glimpse into what awaits you in our upcoming sessions: \n8 November 2024 – Introduction session \n15 November 2024 – Required investments \n22 November 2024 – NB Selection \n2 December 2024 – QMS & TD Development \n4 December 2024 – NPV \n13 December 2024 – Wrap up
URL:https://nobocap.eu/event/short-course-on-training-for-c-level-management-2/
LOCATION:ZOOM
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20241219T100000
DTEND;TZID=UTC:20241219T120000
DTSTAMP:20260430T134146
CREATED:20241213T140851Z
LAST-MODIFIED:20241213T140851Z
UID:13577-1734602400-1734609600@nobocap.eu
SUMMARY:NoBoCap Community Online Webinar
DESCRIPTION:We are excited to invite you to the NoBoCap Community Online Webinar\, where we will come together as clusters\, innovation hubs\, knowledge and supportive partners to share insights and prepare for a successful year ahead. Join us to learn about our initiatives\, tools\, and plans. \nEvent Details: \n\nDate: Thursday\, December 19\, 2024\nTime: 10:00–12:00 CET\nLocation: Online\nJoin via Zoom:  https://us02web.zoom.us/j/85357869276\n\nWhy Join Us? \nThis webinar is tailored for forward-thinking clusters and organizations looking to: \n\nConnect with an active network of innovation hubs and partners.\nLearn how NoBoCap tools and services can strengthen your impact in unlocking MRD and IVR.\nStay ahead of EU policies for medical device certification and initiatives shaping the future of collaboration.\nExplore opportunities for growth and support within a vibrant community.\n\n  \nPreliminary Agenda: \n\nWelcome to New Members and Partners\nThe Community Activities of 2024 and Plans for 2025\nA Voice to EU Policy and EU Initiatives\nNoBoCap Backbone Tools & Services: Latest Developments and Plans\nGetting Ready for 2025!\n\nReserve Your Spot: \nClick here to register \n  \nThis is a valuable opportunity to discover how NoBoCap can support your cluster’s success and drive innovation in your field. Don’t miss out—let’s build a stronger future together!
URL:https://nobocap.eu/event/nobocap-community-online-webinar/
LOCATION:ZOOM
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250210
DTEND;VALUE=DATE:20250213
DTSTAMP:20260430T134146
CREATED:20240924T093306Z
LAST-MODIFIED:20251112T150127Z
UID:13393-1739145600-1739404799@nobocap.eu
SUMMARY:Short Course on AI-supported Medical Devices
DESCRIPTION:Mark your calendars for 10-12 February 2025 and join us for an immersive 3-day training in Leuven! Here’s a glimpse into what awaits you in our upcoming modules: Module 1 – Introduction to the Course and the Regulatory Background Module 2 – Introduction to AI Module 3 – AI Evaluation and Model Performance Metrics Module 4 – Introduction to Statistics Module 5 – Introduction to Advanced Model Evaluation Topics \n\n \nEvent Details:\n\n\n\n\nDates: 10-12 February 2025\n\n\n\nLocation: Leuven\, Belgium\n\n\n\nDuration: 3 full days of training\n\n\n\n\n\n\n  \nThe first cycle of this course has been successfully completed!To pre-register for the next cycle\, please complete the form. \nReady to Get Started?\nClick HERE to Pre-Register for the course! \nWe kindly ask you to fill out the pre-registration form carefully and review the disclaimer to ensure a smooth enrollment process for our upcoming short course!
URL:https://nobocap.eu/event/short-course-on-ai-supported-medical-devices/
LOCATION:Leuven\, Belgium\, Leuven\, Belgium
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250210
DTEND;VALUE=DATE:20250422
DTSTAMP:20260430T134146
CREATED:20250130T085110Z
LAST-MODIFIED:20250130T085110Z
UID:13614-1739145600-1745279999@nobocap.eu
SUMMARY:Module 1: Implementing Regulatory Requirements for Medical Devices
DESCRIPTION:Unlock the skills you need to become an expert in Medical Devices Regulation (MDR) with our online postgraduate-level courses! \nWhether you’re aiming to work in medical device manufacturing\, auditing\, or product assessment\, this module is your first step toward achieving MDR compliance. It’s a 10-week\, 100% online course that offers 5 CPD credits and a Postgraduate Certificate accredited by theUniversity of Medicine\, Pharmacy\, Sciences and Technology of Târgu Mureş. \nFirst Step! Create your account on the NoBoCap Environment at https://portal.nobocap.eu\, then find Post Graduate Courses section and register for the Module 1. \nDon’t miss this opportunity! Secure your spot today—places are limited. Register now before it’s too late! \nModule 1 starts in February 10\, 2025. \nClick here on https://portal.nobocap.eu and take the next step toward enhancing your MedTech career!
URL:https://nobocap.eu/event/module-1-implementing-regulatory-requirements-for-medical-devices/
LOCATION:ZOOM
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20250220T110000
DTEND;TZID=UTC:20250220T130000
DTSTAMP:20260430T134146
CREATED:20250214T111859Z
LAST-MODIFIED:20250214T111859Z
UID:13669-1740049200-1740056400@nobocap.eu
SUMMARY:NoBoCap Community Online Webinar
DESCRIPTION:We are pleased to invite you to the upcoming monthly webinar of the NoBoCap European Community of Innovation Hubs\, Clusters\, and Partners focused on unlocking MDR/IVDR regulation for innovation. This virtual meeting will bring together Innovation Hubs\, Clusters\, and Partners to collaborate on unlocking MDR & IVDR for innovation. \n📅 Date: 20 February 2025  \n📌 Registration: please register here: https://eu4healthsolutions.formstack.com/forms/nobocap_community_online_webinar_02_2025 \n(Your registration details will be used for sharing webinar materials.)
URL:https://nobocap.eu/event/nobocap-community-online-webinar-2/
LOCATION:ZOOM
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250428
DTEND;VALUE=DATE:20250708
DTSTAMP:20260430T134146
CREATED:20250313T114215Z
LAST-MODIFIED:20250403T151033Z
UID:13691-1745798400-1751932799@nobocap.eu
SUMMARY:Module 3: Generating Data for Technical Documentation (IVDR)
DESCRIPTION:Master the Art of IVDR Compliance with Our Online Postgraduate Course! \nNeed to navigate the complexities of the In Vitro Diagnostic Devices Regulation? This is your chance to gain the expertise needed to construct a Technical File and Performance Evaluation Report – two essential elements for regulatory compliance. \nModule 3: Generating Data for Technical Documentation (IVDR) is a 10-week\, 100-hour online course designed for professionals looking to build on their scientific and engineering knowledge in the IVD sector. Upon completion\, you’ll earn a 5-credit EQF7 Certificate\, equipping you with advanced regulatory skills. \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 Module 3. \nSave the date! Secure your spot early – places are limited. Don’t miss this opportunity to advance your career in IVDR compliance! \nModule 3 starts on April 28\, 2025. \nClick here on https://portal.nobocap.eu and take the next step toward enhancing your MedTech career!
URL:https://nobocap.eu/event/module-3-generating-data-for-technical-documentation-ivdr/
LOCATION:ZOOM
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250516
DTEND;VALUE=DATE:20250628
DTSTAMP:20260430T134146
CREATED:20250327T135058Z
LAST-MODIFIED:20250328T143146Z
UID:13708-1747353600-1751068799@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. \n\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📅 16.05.2025The 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\n• Which investments are needed to bridge the “regulatory valley of death” in Europe?📅 23.05.2025This 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\n• How to select your Notified Body for your innovative MedTech product📅 06.06.2025Learn 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\n• How to develop and implement an effective Quality Management System and high-quality technical documentation📅 13.06.2025This 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\n• How to learn from a best-practice case of a start-up that invests at the right time📅 20.06.2025This 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\n• Closing session📅 27.06.2025The 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/
LOCATION:ZOOM
ATTACH;FMTTYPE=image/png:https://nobocap.eu/wp-content/uploads/2025/03/NoBoCap-short-course.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250519
DTEND;VALUE=DATE:20250729
DTSTAMP:20260430T134146
CREATED:20250428T085131Z
LAST-MODIFIED:20250428T090237Z
UID:13741-1747612800-1753747199@nobocap.eu
SUMMARY:Module 2: Generating Data for Technical Documentation (MDR)
DESCRIPTION:Master MDR Compliance with Our Online Postgraduate Course! \nNeed to navigate the complexities of the Medical Device Regulation (EU 2017/745)? This is your chance to gain the expertise needed to construct a Technical File and Clinical Evaluation Report – two critical pillars for regulatory compliance. \nModule 2: Generating Data for Technical Documentation (MDR) is a 10-week\, 100-hour online course designed for professionals looking to deepen their scientific and engineering knowledge in the Medical Devices sector. Upon completion\, you’ll earn a 5-credit EQF7 Certificate\, giving you advanced capabilities to meet the demands of the MDR. \n🔹 First step! Create your account on the NoBoCap Environment at https://portal.nobocap.eu.🔹 Next! Go to the NoBoCap Courses section and register for Module 2 before May 9\, 2025. \nSave the date! Secure your spot early – places are limited. Don’t miss this opportunity to boost your expertise in MDR compliance! \nModule 2 starts on May 19\, 2025. \nClick here: https://portal.nobocap.eu and take the next step toward advancing your MedTech career!
URL:https://nobocap.eu/event/module-2-generating-data-for-technical-documentation-mdr/
LOCATION:ZOOM
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20251015
DTEND;VALUE=DATE:20251017
DTSTAMP:20260430T134146
CREATED:20250819T133913Z
LAST-MODIFIED:20250819T134445Z
UID:14077-1760486400-1760659199@nobocap.eu
SUMMARY:Summit by NoBoCap Community 2025
DESCRIPTION:Summit by NoBoCap Community unlocking the MDR/IVDR regulation for innovators in Europe. \nThe Summit will take place between 15-16 October\, two days of in-person high-level dialogues and sessions\, in Brussels. \nHear the speakers discuss building your knowledge about MDR\IVDR requirements\, gain insights from EC Representatives on the evolving EU regulatory environment\, and participate in workshops and panel discussions. \nJoin NoBoCap Community Summit to stay ahead in the evolving regulatory landscape and ensure your innovations comply with MDR/IVDR requirements. \nRegistration is for NoBoCap Community Members and partners and for Innovation Hubs/Clusters\, Know-How Partners and Notified bodies interested in the Activities of the Community to unlock MDR/IVDR for Innovation. \n\nMore information you will find on our website!
URL:https://nobocap.eu/event/summit-by-nobocap-community-2025/
LOCATION:Brussel\, Brussel\, Belgium
END:VEVENT
BEGIN:VEVENT
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
END:VEVENT
BEGIN:VEVENT
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
END:VEVENT
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
END:VEVENT
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
END:VEVENT
BEGIN:VEVENT
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
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