C-level Management Training

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
📅 16.05.2025
The 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?
📅 23.05.2025
This 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
📅 06.06.2025
Learn 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
📅 13.06.2025
This 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
📅 20.06.2025
This 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
📅 27.06.2025
The 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.