2 min read
26th November | 14:00 – 18:00 | Medicon Village, Lund, Sweden
Free of Charge
Are you an IVD professional looking to gain insights into the current challenges related to regulatory and clinical requirements? Join us in Lund, Sweden, for an afternoon of knowledge-sharing and networking! Coffee, tea, and light snacks will be available to keep you energized as you connect with fellow professionals and find the answers to your IVDR challenges.
What You Will Learn
New, Stringent Regulatory Constraints Due to IVDR
The unpredictability of the EU IVDR regulation has created challenges for IVD manufacturers, leading many to explore alternative pathways, like the US market or producing research use only (RUO) products. The US market, while governed by the FDA, offers a different set of challenges but can appear more predictable than the evolving EU landscape. Companies must strategically assess market demands, regulatory pathways, and risks to ensure compliance and balance innovation with regulatory obligations.
High-Quality Clinical Performance Data
A strong clinical strategy is essential for IVD success, involving comprehensive clinical performance studies designed to meet stringent regulatory standards like IVDR and ISO 20916. These studies evaluate safety and performance, the clinical benefit of using the device, as well as provide substantial evidence to support claims of safety and performance. High-quality clinical data not only facilitates regulatory compliance but also instills confidence in healthcare providers and patients. By ensuring studies are well designed, manufacturers can streamline market entry and align with user expectations.
Agenda
| 14:00 – 14:15 |
Welcome |
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| 14:15 – 15:00 | Finding the Best Regulatory Pathway and Clinical Evidence Strategy for your IVD |
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| 15:00 – 15:45 | Clinical Performance Studies Under IVDR: Good Study Practice in Compliance with ISO 20916 |
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| 15:45 – 18:00 | Networking Session: Meet fellow IVD professionals and book a free 30-minute slot with our Regulatory, Clinical and Quality experts |
Free IVDR Check-Up
Are you working towards IVDR compliance but need guidance to overcome specific issues you’re facing? During this 1:1 session with the Veranex team, you can ask your IVDR questions or receive our feedback on parts of your technical documentation. Don’t miss this occasion to receive valuable insights from our 20+ years of IVD experience!
Team
Veranex delivers exceptional assistance in the design, engineering, and manufacturing of diagnostic technologies, leveraging our deep expertise in user experience and interface design. Our team of experts guides clients through the complex regulatory, quality and reimbursement landscapes, and manages clinical trials on a global scale, so that you can achieve IVDR compliance.
Sofia Spjuth VP, Clinical Affairs, Europe
Frédéric Lefebvre Sr Director, Business Development
Silvia Anghel, PhD Sr Director, Regulatory and Quality Affairs
Francisca Lameiras, PhD Regulatory and Quality Affairs Manager
Sylvain Biéler, PhD Clinical Study Manager
We look forward to meeting you in Lund!
Register Now
3 min read
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