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X-WR-CALDESC:Events for NoBoCap
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DTSTART;VALUE=DATE:20250428
DTEND;VALUE=DATE:20250708
DTSTAMP:20260430T133723
CREATED:20250313T114215Z
LAST-MODIFIED:20250403T151033Z
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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
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DTSTART;VALUE=DATE:20250516
DTEND;VALUE=DATE:20250628
DTSTAMP:20260430T133723
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
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DTSTART;VALUE=DATE:20250519
DTEND;VALUE=DATE:20250729
DTSTAMP:20260430T133723
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
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