Are you navigating the complexities of working with notified bodies in the MedTech field? Join us for an insightful afternoon where we’ll delve into the challenges, pitfalls, and solutions that can make or break your certification process.
At this event, TÜV SÜD will provide a presentation from a notified body’s perspective, highlighting critical factors that can delay or derail the approval process. You’ll gain invaluable insights into avoiding common mistakes, such as missing documentation or choosing the wrong notified body.
We’ll also hear from representatives of three MedTech companies who will share their real-world experiences. They’ll discuss the hurdles they faced when working with notified bodies, how they overcame these challenges, and the lessons they learned to streamline the process.
Finally, a representative will introduce Health Tech Pathways, a platform developed by Health Tech Hub Copenhagen with support from the Novo Nordisk Foundation. Health Tech Pathways leverages AI-driven tools and learning resources to simplify the preparation and validation of regulatory documentation. It also connects startups with experts and fosters a community for sharing experiences and solutions.
This event offers a unique opportunity to learn from both experts and peers, equipping you with the knowledge and tools to optimize your journey through notified body approvals.
We look forward to welcoming you!
Date: Thursday 13th March 2025
Time: 14:00 – 18:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub 2
Program:
| 14.00 | Registration and networking |
| 14:30 | Welcome Anette Steenberg, CEO, Medicon Valley Alliance |
| 14:35 | Insights into a Notified Body’s Processes: Client Onboarding, Conformity Assessment, and how to prevent delays in CE Certification Martin Jakobsson, Vice President, TÜV SÜD Denmark Medical Health Services |
| 15:05 | Time lines for product certification with Notified Bodies Charlotte Oom, Director of Quality, Clinical and Regulatory Affairs, CellaVision |
| 15:30 | Maintaining a Long-term Relationship with a Notified Body Benedikte Blom, Director Regulatory Affairs, Chronic Care, Global Quality & Regulatory Affairs, Coloplast |
| 15:55 | Coffee Break |
| 16:25 | Navigating Compliance as a Start-Up: Trial, Error, and Growth Esteban Sánchez Márquez, RA/QA Manager, Suturion |
| 16:50 | Introducing Health Tech Pathways: smarter regulatory support and services for health tech startups Martin Broch Pedersen, Business Development Director, Health Tech Hub Copenhagen |
| 17:20 | Networking and light snack |
| 18:00 | End of meeting |
Speakers
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Martin Jakobsson, Vice President, TÜV SÜD Denmark Medical Health Services He joined the expert management team behind TÜV SÜD Notified Body 2443 in its start-up phase in April 2021 as Head of Operations, tasked to establish a fully operational certification business with lean processes for conducting conformity assessments on medical devices according to MDR 2017/745. Upon his appointment in Jan 2022 as VP, Martin led NB 2443 up to its designation in April 2024 and since then into full operations based on a customer journey uniquely mapped to reduce complexity, from pre-application to certification. |
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Charlotte Oom, Director of Quality, Clinical and Regulatory Affairs at CellaVision in Lund. With 13 years within the company and a foundation in software development and testing, she combines technical expertise with a passion for navigating complex regulatory landscapes. Charlotte is motivated by challenges, at work as well as outside. |
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Benedikte Blom, Director Regulatory Affairs, Chronic Care, Global Quality & Regulatory Affairs, Coloplast. Started in the medical device industry in 2007 as a Certification Coordinator at the Danish Notified Body DGM (now DNV). She later became Quality Manager before moving to GN Otometrics as an RA Specialist in 2014. Since 2016, she has worked in Regulatory Affairs at Coloplast, specializing in registrations, product development, lifecycle management, and regulatory submissions, including Notified Body technical files and 510(k) submissions. |
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Esteban Sánchez Márquez, RA/QA Manager, Suturion. Esteban is a patient-driven Pharmaceutical Engineer with extensive experience in Quality Management Systems and global Regulatory Affairs for medical devices. As Quality and Regulatory Manager at Suturion AB, he is responsible for regulatory approvals (i.e. CE marking, FDA clearance) and QMS compliance with ISO 13485 and MDSAP. |
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Martin Broch Pedersen, Business Development Director at Health Tech Hub Copenhagen. Martin brings over 20 years of global experience in technology, digital healthcare, and business development. With a background in computer science and economics, he has successfully led digital transformations across startups, small organizations, and large corporations. Martin is passionate about leveraging technology to create user-friendly, evidence-based, and transparent health solutions. |
Deadline for registration is 12 March 2025
The MVA MedTech Network is a professional network for Medicon Valley Alliance members from industry, academia and health care sector with interest in the MedTech field. Joining the network is free of charge but is limited to Medicon Valley Alliance members.
However, non-member organizations and companies are welcome to attend one network event to evaluate if joining the network is relevant. If so, becoming a member of Medicon Valley Alliance will automatically allow you to join the MedTech network.
For more information please contact Katrine Brems Olsen kbo@mva.org
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