New Strategic Alliance with IVDEXEL: Simplified Access to the Australian Market for Medical Devices

🌏 Exciting Strategic Partnership! 🚀We are thrilled to announce our collaboration with IVDEXEL, a leading company specializing in the registration of medical devices and in vitro diagnostic (IVD) products in Australia. This partnership strengthens our commitment to providing comprehensive and effective regulatory compliance solutions in one of the most demanding markets globally. Through this alliance, […]
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Post-MDCG-2020-16-rev.2

Updated guidance 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟬-𝟭𝟲

📝 Updated guidance 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟬-𝟭𝟲 "𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝗖𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗥𝘂𝗹𝗲𝘀 𝗳𝗼𝗿 𝗶𝗻 𝘃𝗶𝘁𝗿𝗼 𝗗𝗶𝗮𝗴𝗻𝗼𝘀𝘁𝗶𝗰 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝘂𝗻𝗱𝗲𝗿 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 (𝗘𝗨) 𝟮𝟬𝟭𝟳/𝟳𝟰𝟲" 📎 The main update has been in rule 3(f) about companion diagnostics (CDx), where more examples of CDx products and products that are not considered CDx have been added. ✏️ This revision also has a flowchart […]
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DARAPY MedTech Consulting es una empresa de consultoría especializada en dispositivos médicos in vitro (IVD). Brindamos una amplia gama de servicios en Desarrollo de Productos (Inmunología y Diagnóstico Molecular), Asuntos Regulatorios, Estudios de Evaluación de Rendimiento y Servicios de Aseguramiento de la Calidad, desde etapas iniciales hasta productos para diagnóstico in vitro (IVD) bien establecidos.