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!

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 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!

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 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!

Summit by NoBoCap Community 2025
2025-10-15 - 2025-10-16 | Brussel, Brussel, Belgium
Summit by NoBoCap Community unlocking the MDR/IVDR regulation for innovators in Europe.
The Summit will take place between 15-16 October, 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!

C-level Management Training
2025-11-07 - 2025-12-12 | 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📅 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Short Course on Performance Evaluation of AI-based MDSW
2026-01-12 09:30 - 2026-01-16 12:00 UTC | Online
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.

Why This Course Matters:
In 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.
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
What You Will Learn:

Smart Metric Selection: Discover how to choose the right performance metrics and avoid their misuse.
Confidence Intervals & Sample Sizes: Master statistical essentials for robust model evaluations.
AI Regulation in Europe: Understand the regulatory framework surrounding AI-based medical devices.
Advanced Topics: Dive deep into model bias, fairness, explainability, monitoring, and robustness evaluation.

Who Should Attend:
This 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.

MedTech Winter School: From Design to Clinical Evidence
2026-01-26 08:00 - 2026-01-28 17:00 UTC | WATT The Health, Kliniekstraat 27a, 9050 Gent, Belgium, Kliniekstraat 27a, 9050 Gent, Belgia, Gent, Gent, Belgium
*Starting January 2026, registrations for the MedTech Winter School: From Design to Clinical Evidence are accepted only for online participation.

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.
A 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.
The course takes place over 3 days during the week of 26 January 2026 (26–28/01), CET.
Onsite participation will be hosted at WATT The Health, Kliniekstraat 27a, 9050 Gent, Belgium.

Module 2 – Generating Data for Technical Documentation (MDR)
2026-05-05 - 2026-07-14 | Online
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.
This 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.
The 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.
Participants 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.
The course will begin on 5 May 2026.
To 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).
Places are limited.

Short Course on EU MDR/IVDR & FDA QMSR
2026-05-07 10:00 - 11:15 UTC | Online
07 May 2026 | 10:00–11:15 | Online

Navigating the shifting regulatory landscape: EU MDR/IVDR, FDA QMSR, and what it means for your QMS

The 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.

Meanwhile, 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.

Session objectives

Understand the key changes proposed under EU MDR/IVDR and the new FDA QMSR, and the rationale behind them

Learn how evolving FDA expectations around AI and cybersecurity are reshaping documentation and validation requirements

Identify common pitfalls in FDA submissions and how to avoid them

Translate regulatory changes into concrete implications for your QMS, including audit and inspection readiness

Speakers

Sophie Smolders, StingOrg

Ruth Beckers, Qualix

Mieke Janssen, pRA Consulting

Moderated and hosted by Sandra Van Londen, HQ Vector

Session outline

Welcome and Introduction

Presentation 1: EU MDR/IVDR and US FDA QMSR: Background, rationale and key changes, Ruth Beckers, Qualix (15min)

Presentation 2: Regulatory changes at the FDA — why good submissions still trigger difficult questions, Mieke Janssen, Pra Consulting (15 min)

Presentation 3: From regulation to reality, what these changes mean for your QMS and audit readiness, Sophie Smolders, StingOrg (15 min)

Moderated panel discussion and Q&A (20 min)

How to register

To register for the Short Course on EU MDR/IVDR & FDA QMSR:

Create an account on the NoBoCap Portal:
www.portal.nobocap.eu

Navigate to the NoBoCap Courses section and select
Short Course on EU MDR/IVDR & FDA QMSR

Places are limited, and early registration is recommended.

Online Workshop: From Innovation to CE-Marking: Smart NoBoCap E-Tools for HealthTech, MedTech and Digital Health SMEs
2026-05-21 14:00 - 15:00 (Europe/Bucharest) | ZOOM
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

This 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.

Date: 21 May 2026

Time: 13:00-14:00 CET

🔗 Register: HERE

(Your registration details will be used for sharing webinar materials.)

The session will include:

• introduction to NoBoCap E-Tools by Luminita Arhip, Altfactor;
• 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;
• demonstration of NoBoCap Matchmaking Innovation – Notified Body, presented by Luminita Arhip, Altfactor, together with IRHIS SME Vilimed;
• announcement of upcoming NoBoCap trainings by Camelia Bulat, ROHEALTH.
