MiMARK Diagnostics’ Post

We are ready for MEDICA - Leading International Trade Fair 2024! CMC Medical Devices team is already in Düsseldorf, prepared to kick off this exciting edition of one of the world's most important healthcare fairs. Come visit us and discover how we can support you with regulatory challenges and explore the latest innovations in the sector together. You'll find us in Hall 6 - G62. We’re here to assist you and provide the support you need! #MedicalDevices #MedTech #HealthcareInnovation #DigitalHealth #PatientSafety #MedicalTechnology #HealthcareSolutions #RegulatoryAffairs #ClinicalTrials #HealthcareIndustry #MedicalDeviceManufacturing #MedDeviceRegulations #MedicalDeviceDesign #HealthcareStandards #GlobalHealth #ConnectedHealth #SmartHealthcare #HealthTech #WearableTechnology

Struggling with disorganized schedules ❌ and missed connections 😓 at medical congresses? Discover how the latest event tech can transform your experience... Back from an exhilarating ASCO Medical Congress in Chicago, Event Cadence continues to set new standards in event technology. Here's a sneak peek into how we made a difference: 📅 Seamless Appointment Scheduling: Over 4,000 confirmed appointments in 100+ rooms—our platform ensures every interaction is perfectly coordinated and tracked. 🔍 Platform Excellence: From room bookings to appointment reminders, our platform handles every detail, making us the preferred choice for pharmaceutical engagements. 🤝 Unmatched Support: Our Customer Success leads and team of contractors provided exceptional support, ensuring flawless execution for our customers. 📊 Actionable Analytics: Advanced reports offered valuable insights, helping our clients refine their planning and boost future event success. Read the full article to learn more: https://hubs.ly/Q02ChGw_0 #medicalmeetings #medicalcongress #ASCO #ASCO2024 #pharmaevents #eventtech #eventtechnology

Good analysis, in a nutshell

🩺 Medical congresses in Greece are a difficult task and it can be overwhelming to juggle all the moving pieces that go into creating a successful event. 👉 That’s why our medical congress services are designed to help you plan, organize, and execute a successful event from start to finish. #medicalcongress #congress #mideasttravel #mideast #mice #businesstravel #synedria #συνεδρια #medical

Raybloc at Medica 2024: Taking Radiation Shielding to the World Stage 🌍 Last week, Raybloc attended MEDICA - Leading International Trade Fair, one of the world’s leading trade fairs for the medical sector. Our team - Max Haydon, Gavin Mooney, Clarke Haydon, and Iain McIver - had the privilege of engaging with professionals and businesses from across the globe, sharing insights, building relationships, and learning about the latest trends shaping healthcare environments worldwide. What stood out to us at Medica was the shared commitment to improving patient and staff experience, with safety and innovation at the forefront. We’re taking what we learned at Medica back to 'The Bloc', channelling these insights into solutions that will not only protect but also enhance the environments where care happens. If you’re a business seeking reliable radiation shielding solutions or looking to partner with us, let’s talk! Together, we can make healthcare spaces safer and more effective for everyone. #Medica2024 #Raybloc #RadiationShielding #GlobalExpansion #MedicalInnovation #HealthcareSolutions

Time to plan your 2025 activities! Here is one you need to mark in your calendars…

Together with Hanaa SAFYA, PhD, we are eager to connect and discuss with you how our latest advanced technologies that might support your Diagnostics R&D goals.   Our ♨️ topics this year include   ➡️The COLPLEX technology, a multiparametric point of care diagnostics. This alternative to the long-established streptavidin/biotin capture system with the unique advantage of multiplexing capacity. We have successfully demonstrated - through a grant from the BMGF (see Multiway https://lnkd.in/dUgKN_UX ) - that COLPLEX can outperform current limitations of multiplexing lateral flow assay, notably in sensitivity. The COLPLEX technology represents a widely applicable and cost-effective advance in immunoassay technology for new diagnostic applications associated with medical needs requiring high-performance multiplex rapid tests   ➡️A blood based-transcriptomic signature capable of differentiating active tuberculosis patients from healthy and asymptomatic latently infected individuals and allowing to monitor tuberculosis treatment and predict therapy outcome. This signature is ready to be out-licensed and developed on a commercial PCR platform (see Isit-tb https://lnkd.in/dJnpPzMq )   ➡️Advanced imaging combined with machine learning-based approaches that permit identification and characterization of micro-organisms and their susceptibility to antibiotics from direct clinical samples thus bypassing culture-based methods and reducing time-to-results (see CODIRA https://lnkd.in/dZkreX2U )   ➡️And even more if you are curious, one step beyond (see Diagnostics & Companion Diagnostics https://lnkd.in/dyZUFZ6f )!   🔔 Interested or simply curious? Don’t hesitate to meet us or reach out to Hanaa SAFYA, PhD or me to schedule a meeting. We’re excited to explore how we can partner to bring impactful diagnostic solutions to life!

A busy start to the MedFIT Event conference in Lille. It was inspiring to see a range of companies pitching to the panel in the Start-Up Slam this morning, and there's more to come this afternoon! One thing everyone is talking about though is regulation and route to market, which led me to catch some of the IVDR and MDR session on efficiently developing the right products; 'Innovative thinking or hopeless daydreaming?'   Kyun Thibaut led the panel with Nabil RIAHI, Päivi Leppänen, Susana de Azevedo Wäsch, PhD and Peter Haasjes. There was general consensus that an MDR process usually takes a long 12 months+, and this in turn can negatively impact how attractive a start-up is to European investment. However, Palvi comment that the process had taken her a record 9 months! 👏   The conversation briefly highlighted the positive outcomes from the shift to IVDR/MDR, but it was difficult to ignore the frustration felt by those dealing with the unpredictability of notified bodies. Susana also mentioned how sad it was to see so many medical devices be removed from the market due to the MDR changes, which caused shortages of devices in hospitals. 'It has killed small companies'    Finally, some synergies with recent events I've attended in the US - the theme of reimbursement. While it is necessary to address the requirements, process and overcome the hurdles in any regulatory environment, how technology will be paid for must be assessed as a priority. 'A health technology assessment and how to get the product reimbursed should drive any regulatory decisions.'   More tomorrow on understanding where technology is in its readiness for development and market, and how eg technology Ltd can help. Time for a coffee and pastry now! ☕ 🥐

A team of experts from Emergo by UL will attend Hospitalar. Details below. Many interesting recent regulatory developments in Brazil which Emergo by UL has previously shared, in the event you missed it, this is delineated again below: *Normative Instruction IN 290/2024 on the Equivalent Foreign Regulatory Authority (AREE) and leveraging authorizations from four of the former GHTF founding members with the regulator, ANVISA: https://lnkd.in/gz-KfUth. *Resolution RDC 850/2024 to expand B-GMP certificates supported by MDSAP certificates to four years: https://lnkd.in/gHyheiMV . *Three guidances to further enhance the Resolution RDC 830/2023: https://lnkd.in/gDz_FY3S   and https://lnkd.in/g42YBwUP . *Resolution RDC 848/2024 on Essential Safety and Performance Requirements, note now applies to IVDs as well: https://lnkd.in/grzWqUir . In a few weeks, one of our SMEs (Lilian Pinheiro) hosts an upcoming webinar (30 April) on RDC 830/2023 (on IVDs): https://lnkd.in/gNeQ_gqa. Note questions can be submitted in advance to emergomarketing@ul.com . Global regulatory harmonization is clearly a theme! Go "reliance"! #medicaldevice #regulatory #regulatoryaffairs #ivd #anvisa #webinar #medtech #regulatorycompliance #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory