Magali Wolff’s Post

The In-Vitro Diagnostic Regulation (IVDR) is highly impacting the in vitro diagnostic landscape, as well as relevant to laboratories using their own in-house testing (LDTs). With its extensive experience and knowledge, Tecan has multiple products IVDR certified, enabling seamless product offerings for clinical laboratories in highly regulated markets. We are happy to share our knowledge and invite everyone to join the webinar from the IVDR leaders where Magali Wolff (Tecan) and Fabian Reijn (Diagnotix) will speak about the following topics: • What is IVDR and what are the timelines? • What are the requirements for in-house tests (LDTs)? • What are the next steps for your lab? The webinar is organized by Sciex. Register now, and stay up to date with the IVDR requirements relevant to your lab: https://lnkd.in/dpd-mUMn #lcms #IVDR #Tecan

Colleagues in the LC-MS clinical environment are grappling with the challenges posed by the end of the IVDR transition period. Are you facing similar hurdles? Our upcoming webinar presents a prime opportunity to gain crucial insights and connect with experts who comprehend the entirety of the workflow. Don't let this pivotal moment slip away. Seize the chance to enhance your expertise and overcome the challenges on the horizon. Register now to chart your course to success!

Join the webinar to learn more about this interesting topic!

🔬 What to do about your LDTs (Laboratory Developed Tests)? 🤔 Join me at ADLM (Association for Diagnostics & Laboratory Medicine) in Chicago tomorrow! Let’s talk about risk profiles, gap analysis, and regulatory support for LDTs, IVDRs, Breakthrough IVDs, CDx, and more. ECI can help! Will you be there? Let’s connect! 🤝✨ #LDT #ADLM #RegulatorySupport #Diagnostics #IVDR #CDx

Earlier this week, James Lappin (Head of Clinical Compliance & Quality Assurance at ARC Regulatory) presented at the MedTech Summit in Brussels on 'In Vitro Diagnostics in Precision Medicine Clinical Trials: Strategies for Success'. His presentation included: 1. A brief overview of the regulatory requirements for implementing IVDs/CDx in a precision medicine trial. 2. Key considerations for Sponsors planning precision medicine clinical trials 3. Lessons learned from using CDx in clinical trials in the EU & US Couldn't join us? Scan the QR code below to receive a copy of this presentation 📥 #MedtechSummit #IVDR #PrecisionMedicine #ClinicalTrials #TeamARC #CRO #IVD #CDx

How is your organization preparing for the IVDR changes? In the rapidly evolving medical landscape, the upcoming deadlines for the new In Vitro Diagnostic Regulation (IVDR) present both challenges and opportunities. The transition to compliance is critical for ensuring your diagnostic applications meet the latest industry standards, paving the way for smoother market access and enhanced patient safety. At TE Connectivity’s Regulatory and Clinical Research organization teams, we understand the complexities involved in navigating these changes. That's why we're offering a free consultation with our seasoned team of experts. Our extensive experience in regulatory affairs and clinical research can provide you with the insights and strategies needed to reduce time to market for your IVDR products. This is an ideal time to review your path to compliance and make any necessary adjustments. By scheduling your free CRO consultation today, you're taking a significant step towards turning upcoming regulatory challenges into strategic advantages. Visit https://lnkd.in/dUYavbvu to book your consultation and begin your seamless transition to IVDR compliance. We’re eager to hear from you. Engage with us in the comments below to share insights and learn from peers navigating the same regulatory landscape.

🎙️ We recently had a great conversation with Dr. Stefan Burde, Global Director of the IVD Focus Team at TÜV SÜD. Dr. Burde shared valuable insights on the IVDR and its impact on the in vitro diagnostics industry.   ✨ Key Highlights: * IVDR's significant changes, including more stringent requirements for manufacturers. * TÜV SÜD's role in navigating these new regulations. * The bright future of IVD with technological advancements and regulatory evolution.   🔗 Dive into the full interview for more insights: https://lnkd.in/etHDZBi8   #TÜVSÜD #IVD #IVDR #MedicalDevices

The recent announcement that Italy’s Istituto Superiore di Sanità (ISS) has been designated as the country’s first Notified Body under the EU’s In Vitro Diagnostic Regulation (IVDR) marks an important milestone for both Italy and the broader European diagnostics sector. After a year-long hiatus, the designation of ISS as the 13th organization in the EU to assess products under IVDR is a much-needed boost for an industry under increasing regulatory pressure. At Diaceutics, our expertise in precision medicine allows us to support pharma in integrating diagnostic testing into the treatment pathway, ultimately improving patient outcomes. Read the latest update today to learn how we can help your organization navigate the complex regulatory environment and develop a winning commercialization strategy. Read more here: https://lnkd.in/ef_JMN_w #PrecisionMedicine #IVDR

Are you using LDTs in your lab and feeling overwhelmed by the IVDR changes? We know how challenging it can be to navigate the new regulations. Register for our webinar, "Making sense of IVDR for LC-MS," hosted on SelectScience on June 26, and stay compliant with the latest regulations! #Tecan #IVDR #LCMS

Check out our latest Webinar on IVDR impact for LC-MS laboratories working with LDT! Happy to provide you with valuable insights. #lcms #IVDR #Tecan