MDx CRO

MDx CRO will be speaking at the 𝗣𝗿𝗲𝗰𝗶𝘀𝗶𝗼𝗻 𝗠𝗲𝗱𝗶𝗰𝗶𝗻𝗲 𝗶𝗻 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 this November, hosted by VNA International. Carlos Galamba will be diving into one of the most critical challenges in our field: 𝘂𝘀𝗶𝗻𝗴 𝗰𝗼𝗺𝗽𝗮𝗻𝗶𝗼𝗻 𝗱𝗶𝗮𝗴𝗻𝗼𝘀𝘁𝗶𝗰𝘀 𝗶𝗻 𝗺𝘂𝗹𝘁𝗶-𝗰𝗼𝘂𝗻𝘁𝗿𝘆 𝗘𝗨 𝘁𝗿𝗶𝗮𝗹𝘀 and what this means for 𝗽𝗵𝗮𝗿𝗺𝗮. With the complexities of drug-device combination trials under the new IVDR, he will be sharing insights from our experience at MDx CRO, helping pharma partners and diagnostic companies navigate: 🔬 CTA-level assays 🔬 Full CDx development across all phases of drug-device development. We look forward to connecting with anyone attending the event. 🌐 Visit www.vna-events.com for more info. #PrecisionMedicine #CDx #Oncology #ClinicalTrials #Pharma #IVDR

🚨 𝐇𝐮𝐦𝐚𝐧 𝐅𝐚𝐜𝐭𝐨𝐫𝐬 𝐄𝐧𝐠𝐢𝐧𝐞𝐞𝐫𝐢𝐧𝐠 (𝐇𝐅𝐄): 𝐀 𝐂𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐄𝐥𝐞𝐦𝐞𝐧𝐭 𝐢𝐧 𝐈𝐕𝐃 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 For IVD devices, #usability isn't just a “nice-to-have” — it’s essential, especially for non-professional users. Ensuring your device is user-friendly and minimizes the risk of error is crucial for its success in real-world settings. Dr. Nicholas Wilson, Principal IVD Consultant, explains how complex interfaces and unclear instructions can often result in user mistakes or misinterpretation of results. Devices must be intuitive for users with varying experience levels and fit seamlessly into different environments, whether in busy labs, point-of-care settings, or at home. At MDx CRO, we help clients design IVDs that comply with #IEC62366 and #FDA Human Factors guidance, ensuring products are both safe and market-ready. Our support includes comprehensive #formative and #summative usability evaluations, working closely with manufacturers to minimize costly redesigns and streamline regulatory approval. If you’re preparing a regulatory submission and haven’t fully addressed usability, this post is for you! 👉 Contact us at contact@mdxcro.com to discuss your project in more detail. #IVD #HumanFactorsEngineering #IEC62366 #Usability #MedTech #RegulatoryCompliance #MDx #MedicalDevices

We are now looking for our next #MarketingManager! Check out the advert in the link below 👇

🌍 New MDCG Guidance on CAPA Plan Assessments for Notified Bodies! 📄 The Medical Device Coordination Group (MDCG) has just released the MDCG 2024-12 guidance, providing key updates for Conformity Assessment Bodies (CABs), Notified Bodies (NBs), Designating Authorities (DAs), and Joint Assessment Teams (JATs) involved in medical device regulations under MDR and IVDR. This document offers valuable insights into: 🛠️ Corrective and preventive actions (CAPA) to address non-compliances. 🔍 Root cause analysis to prevent recurring issues. 📝 Templates to make the CAPA review process smoother, more efficient, and consistent. If you’re a Notified Body or part of a regulatory authority, this guidance is an essential resource to improve assessments and ensure compliance with MDR/IVDR standards. ✅ Stay informed, stay compliant! 💡 #MedicalDevices #MDR #IVDR #CAPA #RegulatoryCompliance #MedicalDeviceCertification #NotifiedBodies #HealthcareRegulations #QualityManagement

🔍 Creating Scientific Validity Reports (#SVRs) for #IVDR compliance can be daunting, especially with the immense amount of scientific literature, intricate data extraction, and the need for a structured, regulatory-compliant report. At MDx CRO, we’ve simplified this process for our clients by incorporating #AI-powered tools into our literature search and review workflow. These advanced tools help us swiftly identify both supporting and contrasting evidence, summarize key data, and pinpoint gaps in the literature. This results in 𝐟𝐚𝐬𝐭𝐞𝐫, 𝐦𝐨𝐫𝐞 𝐜𝐨𝐦𝐩𝐫𝐞𝐡𝐞𝐧𝐬𝐢𝐯𝐞, 𝐚𝐧𝐝 𝐡𝐢𝐠𝐡𝐥𝐲 𝐚𝐜𝐜𝐮𝐫𝐚𝐭𝐞 𝐒𝐕𝐑𝐬, all while maintaining top-quality standards. 𝐎𝐮𝐫 𝐀𝐈 𝐢𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐢𝐨𝐧 𝐡𝐚𝐬 𝐚𝐥𝐬𝐨 𝐞𝐧𝐚𝐛𝐥𝐞𝐝 𝐮𝐬 𝐭𝐨 𝐫𝐞𝐝𝐮𝐜𝐞 𝐜𝐨𝐬𝐭𝐬 𝐟𝐨𝐫 𝐨𝐮𝐫 𝐜𝐥𝐢𝐞𝐧𝐭𝐬, reinforcing our commitment to making #medtech accessible to all – from startups to established medical device and IVD companies. 🎥 Check out this video where Dr. Grace Chia explains how these advancements have revolutionized our SVR writing process, allowing us to meet tight deadlines without compromising on quality. By streamlining SVR development with AI, we’re providing faster, more insightful, and reliable results. 👉 Need high-quality SVRs delivered quickly and cost-effectively? Reach out to us at 📩 contact@mdxcro.com, and our team will connect with you within 24 hours. #MedicalWriting #ClinicalResearch #AIinHealthcare #ScientificReview #RegulatoryAffairs #MedTech #Innovation #LiteratureReview #Diagnostics #precisionmedicine

🔍 𝐄𝐧𝐬𝐮𝐫𝐢𝐧𝐠 𝐄𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞 𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 𝐢𝐧 𝐈𝐕𝐃 𝐒𝐭𝐮𝐝𝐢𝐞𝐬 At MDx CRO, effective monitoring is crucial for ensuring patient safety, maintaining data integrity, and achieving regulatory compliance. Spain is becoming an increasingly significant player in IVD performance studies across Europe, with #Catalonia now recognized as one of the top 5 global hubs for research in #precisionmedicine and #oncology. In our latest video series, Clinical Research Manager Yaiza Benito Molpeceres shares essential strategies for 𝐬𝐮𝐜𝐜𝐞𝐬𝐬𝐟𝐮𝐥 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐬𝐭𝐮𝐝𝐲 𝐦𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠. With the growing number of studies conducted in Spain, MDx CRO is here to support diagnostic and pharma companies in navigating their IVDR journey, delivering top-tier clinical research to drive IVD innovation forward. 📽️ Watch the video to learn more! #IVD #ClinicalResearch #IVDR #MedicalDevices #MedTech #Innovation #ClinicalMonitoring

🌍 Greetings from #Budapest! This is why I love what I do—helping brilliant minds navigate the complexities of #MDR, #IVDR, and the evolving #AI Act. After an insightful morning introducing startups across Europe to Regulations and market access, now the fun begins... it's time for 1:1 mentoring in a fast-paced, speed-dating style! I’ll be mentoring at least 8 innovative EU startups and business executives over the next few hours. Really pleased to see the sessions are now fully booked and we are already planning for further mentoring offline :) Grateful to be partnering with EIT Health and DARE Innovations on this initiative. One common theme? Nearly 80-90% of these startups have some level of #AI integration in their products (AI and GPAI). Exciting times ahead! 😉 MDx CRO #MedTech #DigitalHealth #AIAct #Innovation #Startups #HealthcareTransformation

What a fantastic addition to the team as we strengthen our clinical evaluation capabilities! Welcome Emma Cartwright!

💡 MDx CRO is dedicated to advancing the precision medicine community. Next-Generation Sequencing (#NGS) plays a crucial role in this effort by identifying genetic variations that inform personalized treatment decisions. However, validating extensive genetic panels while navigating complex regulatory requirements poses significant challenges. Our IVD Manager, Dr. Marketa Svobodova, PhD, offers expert insights into some of the key hurdles in bringing NGS tests to market under the strict regulations of the #IVDR. At MDx, we have developed targeted strategies that ensure regulatory compliance and robust performance, accelerating the availability of NGS solutions for patients. For guidance on developing your NGS regulatory files and obtaining CE marking, reach out to us at 👉 contact@mdxcro.com Discover more about our work to overcome these challenges and advance precision medicine in this video. #NGS #IVDR #PrecisionMedicine #RegulatoryAffairs #IVD #MolecularDiagnostics #CDx

🔔 Update Alert! The latest version of the MDCG guidance document has been updated with an important new question regarding the application of the designation of European Union Reference Laboratories (EURLs) under IVDR. This addition clarifies key responsibilities for Notified Bodies and manufacturers regarding batch testing and performance verification for Class D devices, with the new requirements taking effect from 1 October 2024. Stay compliant by reviewing the new details in the guidance! #IVDR #MedicalDevices #EURL #RegulatoryCompliance #MedTech