Radiopharmaceutical Imaging and Dosimetry (Rapid), LLC ’s Post

Precise, reliable, and safe thermal management is essential in medical applications such as skin cooling, medical device cooling, patient core temperature management and laboratory equipment cooling. Industry proven by the UK's leading medical companies, our high-performance heat transfer fluids with antifreeze function help to deliver optimum temperature control and significant cooling system performance gains for medical, laboratory and pharmaceutical manufacturing applications. If you require a thermal fluid for your medical laser, MRI scanner, lab cooling equipment or manufacturing operation, we can provide a fluid solution for these and many other medical applications. Read about DTX in the medical sector in our case study below. www.hydratech.co.uk

Is yoyr product and IVD? Clarification on the classiciation of IVDs and Medical Devices, important reference point in the development of new assays. https://lnkd.in/dRqfArdX #IVD #Diagnostics #LaboratoryTesting #RegulatoryAffairs #AssayDevelopment #Biotechnology #HealthTech

🔬 𝗟𝗼𝗼𝗸𝗶𝗻𝗴 𝗳𝗼𝗿 𝗰𝘂𝘀𝘁𝗼𝗺𝗶𝘇𝗲𝗱 𝗶𝗻 𝘃𝗶𝘁𝗿𝗼 𝗲𝗹𝘂𝘁𝗶𝗼𝗻 𝗺𝗲𝘁𝗵𝗼𝗱𝘀 𝗳𝗼𝗿 𝘆𝗼𝘂𝗿 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀?   Traditional dissolution methods often fall short when applied to non-conventional dosage forms such as drug-eluting stents, drug-coated balloons, bioceramic materials, or vaginal rings. However, alternative dissolution techniques, such as the flow-through cell, can be employed to develop sensitive and robust methods for determining the elution of medical devices.   For instance, we developed a sensitive and robust method for determining the elution of two active drug substances from vaginal rings using a USP Apparatus 4 system. This in vitro method was designed for both real-time testing (up to 21 days) and accelerated testing for QC purposes. It successfully discriminates between good and bad batches, has been fully validated according to ICH guidelines, and has received approval from health authorities. The vaginal ring is now on the market, with the accelerated method used for commercial batches.   📄 Read the full scientific publication, **"A Novel Method for the Elution of Sirolimus (Rapamycin) in Drug-Eluting Stents,"** published in *Dissolution Technologies*:   🔗 https://lnkd.in/d44e2xUg   💬 Do you have a similar case and would like to consult one of our experts? Click the link below to ask a question:   👉 https://lnkd.in/dNSJvQEA   #SOTAX #pharma #services #elution #medicaldevices

The medical device contract research organization (CRO) market focuses on providing specialized research services to medical device companies. These CROs assist in various stages of device development, including clinical trials, regulatory submissions, preclinical testing, and post-market surveillance. The increasing complexity of medical device regulations, combined with the need for faster time-to-market, has propelled the demand for outsourcing to CROs in this sector. 𝐅𝐮𝐭𝐮𝐫𝐞 𝐓𝐫𝐞𝐧𝐝𝐬: 𝐀𝐫𝐭𝐢𝐟𝐢𝐜𝐢𝐚𝐥 𝐈𝐧𝐭𝐞𝐥𝐥𝐢𝐠𝐞𝐧𝐜𝐞 𝐚𝐧𝐝 𝐌𝐚𝐜𝐡𝐢𝐧𝐞 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠 𝐈𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐢𝐨𝐧: AI and machine learning technologies are being increasingly used by CROs to analyze clinical trial data faster and more accurately, optimizing trial processes. 𝐃𝐞𝐜𝐞𝐧𝐭𝐫𝐚𝐥𝐢𝐳𝐞𝐝 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬: The COVID-19 pandemic has accelerated the adoption of decentralized or remote clinical trials, which rely on telemedicine, mobile devices, and other digital tools to gather data outside traditional clinical settings. 𝐂𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐯𝐞 𝐏𝐥𝐚𝐭𝐟𝐨𝐫𝐦𝐬: Digital platforms that allow real-time collaboration between medical device companies and CROs are expected to grow, enabling more streamlined communication, project management, and data sharing. 𝐅𝐨𝐜𝐮𝐬 𝐨𝐧 𝐏𝐞𝐫𝐬𝐨𝐧𝐚𝐥𝐢𝐳𝐞𝐝 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: CROs are increasingly working on trials for personalized or patient-specific medical devices, including those made via 3D printing and precision engineering. IMIR Market Research Pvt. Ltd. 𝐆𝐞𝐭 𝐭𝐡𝐞 𝐬𝐚𝐦𝐩𝐥𝐞 𝐜𝐨𝐩𝐲 𝐨𝐟 𝐭𝐡𝐢𝐬 𝐩𝐫𝐞𝐦𝐢𝐮𝐦 𝐫𝐞𝐩𝐨𝐫𝐭: https://lnkd.in/dwUJkxyB 𝐂𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐰𝐨𝐫𝐤𝐢𝐧𝐠 𝐢𝐧 𝐭𝐡𝐞 𝐦𝐚𝐫𝐤𝐞𝐭: 1MED SA 4Clinics 4Pharma Ltd Absorption Pharmaceuticals - Promescent® ABX-CRO advanced pharmaceutical services Forschungsgesellschaft Accell Clinical Research AccelLAB AccuLab Life Sciences Accuprec Research Labs Pvt. Ltd. Acorn Regulatory Consultancy Services Limited Acrapack Pty Ltd acromion GmbH Across Medical ACT FARMA CRO Activa-Cro ADAX'O INTERNATIONAL Advanced Drug Dectection Advanced Medical Solutions Affinity Bio Partners, LLC Afortiori Development Ltd Afra Pharma consultant Aginko Research AG  AICROS AJW Technology Consultants Alera Labs, LLC Alira Health ALTIORA CRO  AlvaMed, Inc. Amarex Clinical Research, LLC, an NSF company American Preclinical Services, Now Part of NAMSA AmeRuss Clinical Trials, LLC Amulet Anagram analyze & realize GmbH Andaman Medical Antrix ABIOGEN PHARMA S.P.A. A-pharmaconsult sas APICES CRO #clinicalresearch #clinicaltrials #medicine #research #healthcare #medicalresearch #clinicaltrial #science #clinical #health #clinicalstudies #pharma #medical #pharmacy #biotech #covid #biopharma #pharmaceuticals #clinicalstudy #pharmacovigilance #medicalaffairs #clinicalresearchassociate #pharmaindustry #doctor #pharmaceuticalindustry #phd #oncology #drugdevelopment #cra #biotechnology

Clinical Trial Imaging Market Size, Share & Trends Analysis Report By Modality (Computed Tomography, Magnetic Resonance Imaging, Ultrasound, Positron Emission Tomography, X-Ray, Echocardiography, Other Modalities), By Product & Services (Software), By End-User (Pharmaceutical Companies, Biotechnology Companies, Medical Device Manufacturers, Contract Research Organizations, Academic and Government Research Institutes, Other End-Users), COVID-19 Impact Analysis, Regional Outlook, Growth Potential, Price Trends, Competitive Market Share & Forecast, 2022 - 2028. 🌐𝐈𝐌𝐈𝐑 𝐌𝐚𝐫𝐤𝐞𝐭 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐏𝐯𝐭. 𝐋𝐭𝐝. 𝐆𝐞𝐭 𝐭𝐡𝐞 𝐬𝐚𝐦𝐩𝐥𝐞 𝐫𝐞𝐩𝐨𝐫𝐭: https://lnkd.in/dbW8sqxy 𝐂𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐰𝐨𝐫𝐤𝐢𝐧𝐠 𝐢𝐧 𝐭𝐡𝐞 𝐦𝐚𝐫𝐤𝐞𝐭: ABX-CRO advanced pharmaceutical services Forschungsgesellschaft Judi by AG Mednet, Inc. ANGLE Bioclinica Biomedical Systems BioPharma Services Inc. Biospective Inc. Biotrial Boston Imaging Core Lab, LLC CALYX Cardialysis CBCC Global Research CCBR Clinical Research (Now Bioclinica) Cellphire Therapeutics, Inc. Center for Diagnostic Imaging (CDI) Certus International, Inc. Clario CÚRAM, SFI Research Centre for Medical Devices Dassault Systèmes Elephas ERESEARCH TECHNOLOGY, INC ERT, Inc. G42 Healthcare icometrix ICON plc Image Core Lab Imaging Endpoints Insight Imaging Intrinsic Medical Imaging IXICO Median Technologies Medical Metrics, Inc. Catalent Pharma Solutions Medpace MERIT CRO Micron Technology Mint Medical, a Brainlab company Navitas Clinical Research #clinicaltrial #clinicaltrials #clinicalresearch #clinicalstudies #clinical #research #medicine #biotech #healthcare #biopharma #medicalresearch #pharma #pharmaceuticals #health #science #covid #pharmaindustry #medical #clinicalstudy #pharmacovigilance #pharmacy #medicalaffairs #oncology #researchstudy #pharmaceuticalindustry #clinicalresearchassociate #phd #cra #drugdevelopment #biotechnology

⏰ Time is ticking for medical device and in vitro diagnostic manufacturers! MDR and IVDR compliance deadlines have been and are fast approaching. Miss these crucial dates and face severe consequences, including product removal from the global markets! The European Medical Devices Regulation (MDR) 2017/745 has several deadlines for manufacturers, see below the recap of deadlines for manufacturers: September 26, 2024: Manufacturers must have a formal written agreement with the notified body. November 1, 2024: The transition arrangement for software-based medical devices ends – the EU AI Act and subsequent focus on risk has also become law as of the 1st of August 2024 with added compliance. May 2026: Class III custom-made implantable devices must transition to MDR. December 31, 2027: Class III devices, class IIb implantable devices (except sutures, staples, dental fillings, etc), and up-classified legacy devices must transition to MDR. December 31, 2028: Other class IIb, class IIa, class I, devices must transition to MDR. IVDR As of July 9, 2024, the European Commission has extended the transitional period for the In Vitro Diagnostic Devices Regulation (IVDR). The new deadlines are: - Class D: December 31, 2027 - Class C: December 31, 2028 - Class B and Class A Sterile: December 31, 2029 Don't Go It Alone! Compliance is critical. Mistakes are costly, and non-compliance is a risk to your market share. Apotech's expert team has successfully supported over 300+ companies through the complexities of MDR and IVDR and much more. Let us handle the heavy lifting while you focus on innovation. Our comprehensive solutions include: - Outsourced MDR/IVDR project management - Integrated QA/RA/Clinical support for seamless compliance Ready to secure your product's future? Contact us today for a consultation.

Medical device leak testing is considered a critical step in ensuring package integrity primarily due to its sensitive nature. Leaks in the device can cause serious health risks to the patients and result in huge financial losses to the manufacturer. Check out our latest to find out how PTI's Seal-Scan technology ensure the integrity of high risk pharmaceuticals and medical devices #leaktest #pharmaceutical #nondestructivetesting https://lnkd.in/gsQh4VSC

*Optimizing Laboratory Efficiency: 20 Key Benchmarks* In laboratory medicine, efficiency is not just about speed—it's about delivering accurate, reliable results swiftly, cost-effectively, and safely. To ensure excellence, it's crucial to benchmark against international standards. Here are 20 critical benchmarks every lab should strive for: 1. **Turnaround Time (TAT):** Achieve ≤1 hour for stat tests, ≤24 hours for routine tests, and ≤72 hours for specialized tests to support timely clinical decisions. 2. **Productivity:** Target 2,500 - 3,000 tests per FTE per month to ensure effective resource use. 3. **Cost per Test:** Maintain $1 - $5 for clinical chemistry and $50 - $100 for molecular diagnostics to ensure financial sustainability. 4. **Error Rates:** Aim for ≤3.4 defects per million tests (Six Sigma level) to safeguard accuracy. 5. **Sample Rejection Rates:** Keep rejections at ≤0.3% to reflect efficient sample handling. 6. **Customer Satisfaction:** Strive for ≥95% satisfaction to demonstrate commitment to client expectations. 7. **Utilization Rate:** Maintain 85% - 90% utilization to optimize resources. 8. **Specimen Collection:** Ensure ≥98% success on first attempt to enhance patient experience. 9. **Automation Index:** Automate 80% - 90% of processes to improve efficiency and reduce errors. 10. **Inventory Turnover:** Target 6 - 8 times per year to minimize waste and maintain supply availability. 11. **Compliance:** Achieve 100% adherence to ISO 15189 or equivalent standards. 12. **Staff Competency:** Ensure 100% certification with ≥20 hours of annual professional development. 13. **Downtime:** Limit downtime to ≤0.5% of total operational hours annually. 14. **Test Menu Breadth:** Offer tests covering ≥95% of common diagnostic needs for comprehensive service. 15. **Sustainability:** Reduce waste by ≥10% and energy use by ≥5% annually. 16. **Patient Safety:** Aim for zero incidents of harm related to lab errors annually. 17. **Waste Management:** Achieve 100% compliance with regulations. 18. **LIS Integration:** Ensure 100% integration with EHRs and hospital systems. 19. **Innovation:** Introduce ≥1 new technology or method annually. 20. **EQA Performance:** Maintain ≥95% of results within acceptable ranges in EQA programs. By targeting these benchmarks, labs can achieve operational excellence, enhancing the quality of care and service delivery. Let’s make these benchmarks our standard practice, ensuring that we continually strive for efficiency and quality in laboratory medicine. **References:** ISO 15189, CLSI, CAP, WHO LQMS Handbook, and more.

How can #medtech companies navigate the new EU Medical Device and In Vitro Diagnostics Regulations? Emma Ritchie (Doyle), Nicole Walsh and Eucharia Commins share their insights ➡️ https://lnkd.in/ekZdtmg9 Irish Tech News

Medical Device Contract Manufacturing Market | Growing at CAGR 11.4%  𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐏𝐃𝐅 𝐒𝐚𝐦𝐩𝐥𝐞 𝐑𝐞𝐩𝐨𝐫𝐭 👉https://lnkd.in/d8n268aq The global medical device contract manufacturing market's revenue was estimated to be worth $78.9 billion in 2024 and is poised to reach $149.4 billion by 2029, growing at a CAGR of 11.4% from 2024 to 2029. Companies From the Market Relievant Medsystems, Inc.   Veranex   Vantage MedTech     CBCC Global Research      Dymax Nextern Collateral Medical Private Limited Orchid Orthopedic Solutions MedTech Executive Search LLC Neuronetics, Inc.    Compliance Group Inc Roche Diabetes Care  StarFish Medical   Tecomet, Inc SPR Therapeutics, Inc.     Bıçakcılar Medical Devices   Sterigenics Skeletal Dynamics Katalyst HealthCares & Life Sciences      PAC - Petroleum Analyzer Company    Grupo Phoenix is now TekniPlex      restor3d ICON plc (formerly Aptiv Solutions) ZOLL Itamar  Profound Medical Inc. Aerotech, Inc.      ILC Dover Acclarent PDI, Inc. Spinal Elements Elligo Health Research      BIOLASE, Inc.      NEOTech Heraeus Medevio  HeartWare Inc Regenity Biosciences Quartesian | Now a Part of Veranex  MCRA Lachman Consultant Services