ARÁNEGA MIRAVITLLES & SUÁREZ ’s Post

In the ever-evolving landscape of medical device regulations, the Predetermined Change Control Plan (PCCP) represents a significant advancement in how the U.S. FDA manages postmarket changes to medical devices. In this article, Yu Zhao from Bridging Consulting LLC will provide an update on the status of the #PCCP, examine regulatory developments, analyze authorized PCCPs, and explore emerging trends and future directions. Read the full article ⤵ https://lnkd.in/dUSYaBVP #medicaldevice #meddevice #medicaldevices #fdaregulation

FDA: Final Guidance on “Remanufacturing“ of Medical Devices The FDA has issued final guidance clarifying "remanufacturing" for reusable medical devices needing maintenace or repair, aiming for consistency and better understanding of federal laws. >>> read more: https://bit.ly/3K7lsji #gmpnews #gmp #FDA #medicaldevices

📢 Update on EU Medical Device and IVD Regulations. On 30 May 2024 the Council of the European Union adopted an amendment to the legislation on medical devices to 'ℎ𝑒𝑙𝑝 𝑝𝑟𝑒𝑣𝑒𝑛𝑡 𝑠ℎ𝑜𝑟𝑡𝑎𝑔𝑒𝑠 𝑎𝑛𝑑 𝑒𝑎𝑠𝑦 𝑡ℎ𝑒 𝑡𝑟𝑎𝑛𝑠𝑖𝑡𝑖𝑜𝑛 𝑡𝑜 𝑔𝑟𝑒𝑎𝑡𝑒𝑟 𝑡𝑟𝑎𝑛𝑠𝑝𝑎𝑟𝑒𝑛𝑐𝑦 𝑎𝑛𝑑 𝑎𝑐𝑐𝑒𝑠𝑠 𝑡𝑜 𝑖𝑛𝑓𝑜𝑟𝑚𝑎𝑡𝑖𝑜𝑛'. The amendment: 🔸 extends the deadline for transitioning to the EUDAMED system under certain conditions 🔸 enables a gradual roll-out of the database 🔸 requires manufacturers to give notice at least six months in advance if they anticipate any interruption or discontinuation of device supply The regulation will enter into force following publication in the EU's official journal. 🔗 Link to document here: https://lnkd.in/dghbuDbc #eudamed #medicaldevices #supplychain #regulatoryaffairs

Successfully marketing a medical device with novel features requires strict compliance. The De Novo classification pathway offers a regulatory route for innovative devices without a predicate in the US market. However, FDA clearances can be challenging as they ensure safety, efficacy, and quality for consumers. Our comprehensive whitepaper delves deep into the De Novo submission process, covering key steps, documentation requirements, manufacturer challenges, and how Cyient can support you in achieving FDA approval. Ready to explore the path to FDA approval? Download our whitepaper now: https://bit.ly/4cMVnCQ #MedicalDevices #FDADeNovo #RegulatoryCompliance #FDAApproval #HealthcareInnovation #DesigningTomorrowTogether #Cyient

🌍 How Medical Device Regulations Are Shaping Global Markets 🚀 What’s changing with Europe’s MDR and how does it differ from the FDA in the USA? Our article explores: 🔑 Key differences between MDR and FDA 🌐 Opportunities to streamline approval across global markets 📈 Leveraging ISO 13485 and MDSAP for faster market entry 🎯 The strategic edge of CE marking for international expansion Read the full breakdown of global regulatory opportunities: https://lnkd.in/dUV_Vmxw #MedicalDevices #MDR #FDA #MedTech #RegulatoryCompliance #ISO13485 #CECertification #HealthcareInnovation Sigrid Uhlemann Heinrich von Mettenheim Michael Bothe Szymon Kurdyn Yuan Li, PhD Lisa Brandon Carrie Beth Johnson Francois Labuschagne Scott Adams Jessica Giles Sabine Müller Gianluca Nasi

🔔 Regulatory Update: Must-Watch for Medical Device Manufacturers! Our latest update on Australia’s regulatory scene: In this video, we’ll cover the new changes to recall procedures following the TGA’s release of URPTG version 2.4 (March 2024). These revisions are designed to streamline and clarify the recall process for therapeutic goods—critical insights you don’t want to miss! 👉 Watch now and ensure your compliance is up to date. Need more information? Contact us! https://hubs.ly/Q02Rn_8G0 #MedicalDevices #RegulatoryUpdate #TGA #RecallProcedures #Compliance #URPTG #MedicalDeviceManufacturers #TherapeuticGoods #AustraliaRegulations #MedTech

🔔 Regulatory Update: Must-Watch for Medical Device Manufacturers! Our latest update on Australia’s regulatory scene: In this video, we’ll cover the new changes to recall procedures following the TGA’s release of URPTG version 2.4 (March 2024). These revisions are designed to streamline and clarify the recall process for therapeutic goods—critical insights you don’t want to miss! 👉 Watch now and ensure your compliance is up to date. Need more information? Contact us! https://hubs.ly/Q02Rn_N90 #MedicalDevices #RegulatoryUpdate #TGA #RecallProcedures #Compliance #URPTG #MedicalDeviceManufacturers #TherapeuticGoods #AustraliaRegulations #MedTech

MedTech Europe has released a new template Manufacturer’s Declaration to support IVD manufacturers’ compliance with Regulation (EU) 2024/1860 with regards to new IVDR transitional provisions. This template is designed to assist manufacturers in: ✅ Declaring eligibility for extended transitional provisions for IVDD devices for which the conformity assessment under Directive 98/79/EC (IVDD) did not require the involvement of a notified body. ✅ Declaring the validity of certificates issued under Directive 98/79/EC (IVDD). ✅ Declaring the compliance of IVD Legacy Devices with the conditions for extended transitional periods outlined in Regulation (EU) 2024/1860. 📄 Learn more and download the template here: https://bit.ly/3zJEo5I

🔍 Discover the updated Australian Regulatory Guidelines for Medical Devices (ARGMD), designed to streamline medical device regulations in Australia. Whether you're a manufacturer, importer, or distributor, this guide is your key to ensuring compliance with the latest safety and performance standards. 💡 Highlights: - Essential Principles checklist to prove compliance. -Step-by-step Conformity Assessment process. -Classification of IVD and medical devices. -Guidelines on ARTG inclusion, fees, and GMDN terms. -Post-market compliance, adverse event reporting, recalls, and more. 🌐 Enhance your global reach with GMND codes and navigate through critical regulations effortlessly. Last updated: 9 December 2024. Explore more: https://lnkd.in/ddYAMvJm Follow us : Biomedista #MedicalDevices #Compliance #Australia #ARGMD #Innovation

Hey everyone, Darren here with another clarifying DP Minute. Today, we're unpacking Comment No. 49 from the QMSR Preamble. Comment #49 asks the FDA to reconsider the scope of 820.10 and define terms like "implantable medical device," “life-supporting,” and “life-sustaining.” Watch the attached video to see how the FDA responded to these suggestions. Our DP Minutes help you navigate medical device regulations. Have questions or want to dive deeper? Visit DPDConline.com and connect with us on LinkedIn. #QMSR #ISO13485 #FDA #MedicalDevices #DPDConsulting #MedicalDeviceRegulatoryConsulting #MedicalDeviceManufacturing #DPDC #MedicalDeviceConsultation #Implant