NoBoCap

Module 2: Generating Data for Technical Documentation (MDR)
2025-05-19 - 2025-07-28 | ZOOM
Master MDR Compliance with Our Online Postgraduate Course!
Need 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.
Module 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.
🔹 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.
Save the date! Secure your spot early – places are limited. Don’t miss this opportunity to boost your expertise in MDR compliance!
Module 2 starts on May 19, 2025.
Click here: https://portal.nobocap.eu and take the next step toward advancing your MedTech career!

C-level Management Training
2025-05-16 - 2025-06-27 | ZOOM
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.
🔹 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.

Here’s a glimpse of what awaits you in the upcoming sessions:
• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Module 3: Generating Data for Technical Documentation (IVDR)
2025-04-28 - 2025-07-07 | ZOOM
Master the Art of IVDR Compliance with Our Online Postgraduate Course!
Need 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.
Module 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.
🔹 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.
Save the date! Secure your spot early – places are limited. Don’t miss this opportunity to advance your career in IVDR compliance!
Module 3 starts on April 28, 2025.
Click here on https://portal.nobocap.eu and take the next step toward enhancing your MedTech career!

NoBoCap Community Online Webinar
2025-02-20 11:00 - 13:00 UTC | ZOOM
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.
📅 Date: 20 February 2025
📌 Registration: please register here: https://eu4healthsolutions.formstack.com/forms/nobocap_community_online_webinar_02_2025
(Your registration details will be used for sharing webinar materials.)

Module 1: Implementing Regulatory Requirements for Medical Devices
2025-02-10 - 2025-04-21 | ZOOM
Unlock the skills you need to become an expert in Medical Devices Regulation (MDR) with our online postgraduate-level courses!
Whether 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.
First 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.
Don’t miss this opportunity! Secure your spot today—places are limited. Register now before it’s too late!
Module 1 starts in February 10, 2025.
Click here on https://portal.nobocap.eu and take the next step toward enhancing your MedTech career!

Short Course on AI-supported Medical Devices
2025-02-10 - 2025-02-12 | Leuven, Belgium, Leuven, Belgium
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

Event Details:

Dates: 10-12 February 2025

Location: Leuven, Belgium

Duration: 3 full days of training

The first cycle of this course has been successfully completed!To pre-register for the next cycle, please complete the form.
Ready to Get Started?
Click HERE to Pre-Register for the course!
We 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!

NoBoCap Community Online Webinar
2024-12-19 10:00 - 12:00 UTC | ZOOM
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.
Event Details:

Date: Thursday, December 19, 2024
Time: 10:00–12:00 CET
Location: Online
Join via Zoom: https://us02web.zoom.us/j/85357869276

Why Join Us?
This webinar is tailored for forward-thinking clusters and organizations looking to:

Connect with an active network of innovation hubs and partners.
Learn how NoBoCap tools and services can strengthen your impact in unlocking MRD and IVR.
Stay ahead of EU policies for medical device certification and initiatives shaping the future of collaboration.
Explore opportunities for growth and support within a vibrant community.

Preliminary Agenda:

Welcome to New Members and Partners
The Community Activities of 2024 and Plans for 2025
A Voice to EU Policy and EU Initiatives
NoBoCap Backbone Tools & Services: Latest Developments and Plans
Getting Ready for 2025!

Reserve Your Spot:
Click here to register

This 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!

Short Course on Training for C-level Management (2)
2024-11-08 - 2024-12-13 | ZOOM
Join us for an exclusive Short Course designed for C-level management professionals!
Here’s a glimpse into what awaits you in our upcoming sessions:
8 November 2024 – Introduction session
15 November 2024 – Required investments
22 November 2024 – NB Selection
2 December 2024 – QMS & TD Development
4 December 2024 – NPV
13 December 2024 – Wrap up

BEHEALTH & DIGITAL 2024 - Hybrid International Event in Healthcare
2024-10-22 - 2024-10-25 | Mihail Kogălniceanu Street, no 5, Cluj-Napoca 400000, Romania, Mihail Kogalniceanu Street, no 5, Cluj-Napoca, Cluj-Napoca, 400000, Romania
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.
This 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.
Again, 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.
Don’t miss this chance to spark innovation and help shape tomorrow’s solutions!
Join us and stay at the forefront of the ever-evolving healthcare landscape!

NoBoCap Community Summit
2024-09-24 13:00 - 2024-09-25 17:00 UTC | Brussel, Brussel, Belgium
Summit by NoBoCap Community unlocking the MDR/IVDR regulation for innovators in Europe.
The Summit will take place on the 24th and 25th of September 2024, two days of in-person high-level dialogues and sessions, in Brussels.
Hear the speakers discuss building your knowledge about MDRIVDR requirements, gain insights from EC Representatives on the evolving EU regulatory environment, and participate in workshops and panel discussions.
Join NoBoCap Community Summit to stay ahead in the evolving regulatory landscape and ensure your innovations comply with MDR/IVDR requirements.
Registration 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.

More information you will find on our website!

NoBoCap Community e-seminar
2024-06-25 09:00 - 10:30 UTC | ZOOM
NoBoCap e-seminar will provide insights into the tools NoBoCap offers in support of building out regulatory expertise and enhancing the preparedness and accessibility to the specific Notified Bodies.
Agenda:
9:00 to 9:10 – WELCOME
9:10 to 9:20 – NoBoCap VOICE – ACCESSIBILITY CHALLENGES AND EU REGULATION (SME – INNOVATION)
9:20 to 9:50 – NoBoCap TOOLS – NOBOCAP E-Guided Tool Demo
9:50 to 10:00 – NoBoCap COURSES planned
10:00 to 10:20 – NoBoCap PARTNERS – Activities
10:20 to 10:30 – NoBoCap Next Events and Summit
Join the e-seminar for an interactive exploration of tools and resources designed to elevate regulatory expertise and accessibility within Notified Bodies.
NoBoCap E-seminars are accessible for NoBoCap Community Members, Partners, and the Members of the Innovation Hubs.

Short Course on Training for C-level Management of MO’s on MDR/IVDR Implementation and Resource Allocation
2024-05-17 - 2024-06-21 | Kasteel Sensum, Kortrijkse steenweg 1026 Gent, Kasteel Sensum, Kortrijkse steenweg 1026, Gent, Belgium
Here’s a glimpse into what awaits you in our upcoming sessions:
17 May 2024 – Face to Face Session – How to successfully market your MedTech product to the European highly regulatory landscape nowadays?

9:30 – Reception with coffee
9:45 to 11:00 – Part I
11:00 to 11:15 – Coffee break
11:15 to 12:30 – Part II
12:30 – Sandwich lunch

24 May 2024 – Webinar – Which investments are needed to bridge the “regulatory valley of death” in Europe?

Time: 13:30 to 14:30

31 May 2024 – Webinar – How to select your Notified Body for your innovative MedTech product?

Time: 13:30 to 14:30

7 June 2024 – Webinar – How to develop and implement an effective quality management system and qualitative technical documentation?

Time: 13:30 to 14:30

14 June 2024 – Webinar – How to learn from a best practice case of a start-up company that invests at the right time?

Time: 13:30 to 14:30

21 June 2024 – Face to Face Session – Exchange the challenges, opportunities, and experiences within the highly regulated European landscape?

9:30 – Reception with coffee
9:45 to 11:00 – Part I
11:00 to 11:15 – Coffee break
11:15 to 12:30 – Part II
12:30 – Sandwich lunch

!!! Face-to-face sessions (17.05 and 21.06) will be held at Kasteel Sensum, Kortrijkse steenweg 1026 Gent.

Equip yourself with the knowledge and strategies to excel in the highly regulated European market and secure your spot now by registering HERE: https://forms.office.com/e/93PczZSs3P

The NoBoCap Community - Welcome to the NoBoCap Community
2024-03-21 13:00 - 16:00 (Europe/Brussels) | ZOOM
The “Welcome to the NoBoCap Community” webinar is exclusively for NoBoCap members and partners.
NoBoCap is an EU co-funded project aiming to empower the MedTech industry by enhancing the efficiency of Notified Bodies and Market Operators, unlocking regulations, and fostering health technology innovation across Europe.
Topics to be covered:

WELCOME: introduction about NoBoCAP
STATUS of build-out community
SERVICES for and VOICE of community
MEETING-UP AND EXCHANGE
Q&A SESSION: feedback and iteration

WHEN: Thursday 21st March (13:00-16:00 CET)

The NoBoCap Community - Building a Community for Innovators to Unlock the EU MDR/IVDR Regulation
2023-11-14 16:00 - 18:00 (Europe/Athens) | ZOOM
Join us in a webinar presenting the NoBoCap initiative on Building a Community for Innovators to Unlock the EU MDR/IVDR Regulation.

NoBoCap is an EU co-funded project aiming to empower the MedTech industry by enhancing the efficiency of Notified Bodies and Market Operators, unlocking regulations, and fostering health technology innovation across Europe.

Topics to be discussed:

The NoBoCap Community – Liz Renzaglia, MEDVIA, NoBoCap Partner

Planned Services and How to Apply – Yves Verboven, EU4 Health Solutions, NoBoCap Partner

A new e-tool to guide innovators on how the new regulation applies and how to identify codes and Notified Bodies – Lean Entries Ltd

EU Surveys on the application and impact of EU regulation on Innovation – GOEG and EY

Q&A and next actions planned

WHEN: Tuesday 14th November (4-6pm, Athens time/ 3-5pm CET)

HOW: By registering HERE.

BeHEALTH – Hybrid International Event in Healthcare
2023-10-24 - 2023-10-26 | Timișoara, Bd. Vasile Pârvan no. 4, Timiș County, România, Bd. Vasile Pârvan no. 4, Timișoara, Timiș County, Romania
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.
With the participation of 100 speakers, including renowned experts, researchers, and entrepreneurs, the event will kick off with an informative plenary session on the latest funding opportunities. Following this, there will be 12 panels addressing current topics relevant to the field, covering its primary areas of activity.
One of these panels is dedicated to our NoBoCap project, titled “MDR and IVD Regulation: Challenges for NBs and Market Operators”, with a unique opportunity for networking and collaboration. Additionally, on the second day of the event, there will be an online training session titled “Introduction to Medical Device Legislation”, organized by the European Commission.
Organized by ROHEALTH – The Health and Bioeconomy Cluster and hosted by the West University of Timișoara, BeHEALTH 2023 propels you into the future of healthcare. Don’t miss this chance to spark innovation and help shape tomorrow’s solutions. Join us and stay at the forefront of the ever-evolving healthcare landscape!

The leading life sciences event in the Baltics
2023-09-20 - 2023-09-21 | Vilnius, Laisvės av. 5, Vilnius, Lithuania
Life Sciences Baltics brings together top decision makers and the next generation of founders and talents from the Baltics, all in one place. They will be joined by CEOs of companies and startups, tech scouts and researchers from all around the world, to create a potential for deep cooperation across traditional boundaries and take up a lasting learning journey. The event is hosted by Innovation Agency Lithuania. Let’s get ahead of the game!
