Matrix Requirements’ Post

New Blog Post: Mastering Medical Device Labeling Best Practices! Proper labeling is critical for ensuring compliance and safety in medical devices. Our latest blog dives into the best practices and key regulatory considerations for effective medical device labeling. Learn how to navigate FDA and EU MDR requirements, use harmonized symbols, and improve your product’s usability and safety. Stay compliant and enhance your product's marketability: https://lnkd.in/eX2NYfS2 #MedicalDevices #RegulatoryCompliance #Labeling #FDA #MDR

📖 INSIGHT: The UDI (Unique Device Identification) and the Eudamed Database are two important requirements of the Medical Device Regulation (Regulation (EU) 2017/745 MDR and Regulation (EU) 2017/746 IVDR respectively), aimed at improving the traceability, safety and management of products within the European Union (EU). This article aims to break down in detail the regulatory and enforcement requirements of UDI and Eudamed, emphasizing their crucial role in regulating of the sector. #MDR #IVDR #medicaldevices #regulatory #regulatoryaffairs #MDGC #UDI #EUDAMED https://lnkd.in/d2_DH-Tn

│NEW ARTICLE│ Learn about the new deadlines for medical device manufacturers to comply with the EU MDR and how to prepare for timely compliance. #medicaldevices #MDR

The medical device industry is only a few years away from the MDD becoming the MDR for CE mark recertification in Europe. On average, it takes 18 months to recertify medical devices – meaning that slower-to-adopt companies may fall behind and risk losing certification altogether. Here’s what companies need to know and what they need to do to successfully recertify:🌐 https://hubs.ly/Q02lpnbT0 #Healthcare #MedicalDevice #MedicalDeviceManufacturing #ContractManufacturing #MDR #CERecertification

Crucial insights into MDR compliance with the essential MDCG 2021-6 Q&A release 📑 Explore "Regulation (EU) 2017/745 - Questions & Answers regarding clinical investigation" – a vital guide for sponsors navigating the MDR landscape. This must-read document provides clarity on Regulation (EU) 2017/745 (MDR) provisions with key questions, giving you detailed information on the regulatory pathway. It covers the complexities of clinical studies, including design considerations, diverse devices, and medicinal products, ensuring compliance with local regulations. Whether you're deeply involved in medical device development or staying updated on regulatory shifts, Rephine Medical Device experts are here to help you navigate this document and others, guiding you through the intricacies of clinical evaluation. Our commitment to you? ✅ Ensuring MDR compliance and achieving CE markings. Let our experts be your partners in medical device excellence. 🌐💡 👇 Connect with our MD Team today Núria de la Fuente Oliva Anna Jordà Coll Andrea Cantero Cantarero 🔗 Read the MDCG 2021-6 Rev. 1 document: https://lnkd.in/dy-tPfX4 #medicaldevices #cemarking #MDCG #clinicalinvestigation

Have you ever been unsure whether the device you work with qualifies as a medical device? You're not alone. Medical devices span a vast range of technologies—there are approximately 2 million types worldwide, as per WHO. They vary in shape, size, functionality, and complexity. With rapid technological advancements, it's increasingly challenging for manufacturers to determine if their product falls under medical device regulations. In this blog, Olivia (Yi-Qin) Sun, Senior Consultant in Regulatory Affairs, offers a step-by-step guide to help you navigate the process of classifying your device in the EU. Don’t miss out on valuable insights to avoid common pitfalls!

Understanding Medical Device Classification https://lnkd.in/g8ynfzrV In our latest blog post we outline medical device classifications in the eye's of the FDA and the criticality of identifying the correct regulatory pathway for your medical device. We also provide some insights on identifying a device's classification. Follow along for more! #medicaldevice #productdevelopment #regulatory

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Mar. 2024 Stay updated on the latest medical device regulatory changes from USA, Europe, and Asia in our March 2024 roundup. Read more: https://lnkd.in/gxhr29hJ #Compliance #GlobalHealth #HealthPolicy #HealthcareIndustry #MedicalDevices #MedicalTechnology #Regulations #RegulatoryUpdates

Are you aware of the US FDA’s medical device classification system? Understanding these classifications is crucial for ensuring compliance as well as the safety and efficacy of medical devices. Read our latest blog, which sheds light on the different classes of devices, factors determining the classification, and Regulatory pathways and exemptions. https://shorturl.at/bgnGH #medicaldevices #usa #usfda #medicaldevice #labeling #regulations #regulatorycompliance #regulatoryaffairs #freyrsolutions #blogs

🌐 Navigating the European Medical Device Regulation (MDR) is paramount for firms looking to market their products in the EU. The MDR brings comprehensive changes, demanding rigorous compliance measures. Check out the key differences between MDD and MDR in this insightful breakdown. 🔍 Read the full article to explore: https://lnkd.in/dc6FTsC5 #MDR #Transition #Medicaldevice #Europeanunion