Jordi Labs, an RQM+ Company reposted this
📢 𝗥𝗤𝗠+ 𝗪𝗲𝗲𝗸𝗹𝘆 𝗪𝗮𝘁𝗰𝗵: 𝗙𝗶𝗻𝗮𝗹 𝟮𝟬𝟮𝟰 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 We introduced our LinkedIn-exclusive newsletter in March of this year and hope you found value whenever clicking through. Today marks our final newsletter for this year. The big news last week from an RQM+ perspective was our presentation and panel discussion on cybersecurity. The slides, recording, and summary of topics discussed with timestamps are available on demand. As you'd expect this time of year, industry news is on the lighter side, but here are a few highlights (links to much more in the newsletter): 🌍 European Key Developments: 🔹 EU MDR/IVDR Q&A updated for Article 10a requirements. 🔹 European Commission opens targeted evaluation consultation on EU MDR/IVDR (closes March 21, 2025). 🔹 UK MHRA updates its Regulatory Reform Roadmap—2025 will be a busy year for MedTech in the UK! 🔎 In the News: ➡️ FDA’s first ‘Early Alert’ pilot: Fresenius infusion pump issue. ➡️ New FDA approvals: Endoquest robotic system, Artivion aortic tear implant, and AngioDynamics prostate cancer ablation. 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 𝘁𝗼 𝗮𝗹𝗹 𝘀𝘂𝗯𝘀𝗰𝗿𝗶𝗯𝗲𝗿𝘀 𝗼𝗳 𝘁𝗵𝗲 𝗥𝗤𝗠+ 𝗪𝗲𝗲𝗸𝗹𝘆 𝗪𝗮𝘁𝗰𝗵! 𝗜𝗳 𝘆𝗼𝘂'𝗿𝗲 𝗻𝗼𝘁 𝘀𝘂𝗯𝘀𝗰𝗿𝗶𝗯𝗲𝗱, 𝘄𝗲 𝘄𝗲𝗹𝗰𝗼𝗺𝗲 𝘆𝗼𝘂 𝘁𝗼 𝗳𝗼𝗿 𝟮𝟬𝟮𝟱. ✨ #MedTech #Cybersecurity #RegulatoryUpdates #MedicalDevices #RegulatoryIntelligence
