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𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗥𝗲𝘃𝗶𝗲𝘄𝘀 𝗪𝗲𝗿𝗲 𝗔𝗹𝘄𝗮𝘆𝘀 𝗟𝗮𝘁𝗲. 𝗦𝗼𝘂𝗻𝗱 𝗙𝗮𝗺𝗶𝗹𝗶𝗮𝗿?   “𝘐 𝘶𝘴𝘦𝘥 𝘵𝘰 𝘴𝘵𝘳𝘶𝘨𝘨𝘭𝘦 𝘵𝘰 𝘬𝘦𝘦𝘱 𝘶𝘱 𝘸𝘪𝘵𝘩 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘶𝘱𝘥𝘢𝘵𝘦𝘴. 𝘐 𝘸𝘢𝘴 𝘢𝘭𝘸𝘢𝘺𝘴 𝘤𝘩𝘢𝘴𝘪𝘯𝘨 𝘪𝘯𝘧𝘰𝘳𝘮𝘢𝘵𝘪𝘰𝘯, 𝘧𝘦𝘦𝘭𝘪𝘯𝘨 𝘭𝘪𝘬𝘦 𝘐 𝘸𝘢𝘴 𝘳𝘶𝘯𝘯𝘪𝘯𝘨 𝘣𝘦𝘩𝘪𝘯𝘥 𝘰𝘯 𝘳𝘦𝘷𝘪𝘦𝘸𝘴 𝘢𝘯𝘥 𝘤𝘰𝘮𝘱𝘭𝘪𝘢𝘯𝘤𝘦 𝘤𝘩𝘦𝘤𝘬𝘴.”   ❌ The problem?   ↳ Spending hours tracking regulatory updates ↳ A lot of different sources, different languages ↳ Manually screening lengthy documents ↳ Risking missed insights in compliance reports   𝗟𝗮𝘁𝗲 𝗿𝗲𝘃𝗶𝗲𝘄𝘀, 𝗺𝗶𝘀𝘀𝗲𝗱 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻, 𝗻𝗼 𝗽𝗿𝗼𝗮𝗰𝘁𝗶𝘃𝗲 𝗶𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻, 𝗮𝗻𝗱 𝗮 𝗹𝗼𝘁 𝗼𝗳 𝘁𝗶𝗺𝗲 𝘀𝗽𝗲𝗻𝘁 𝗼𝗻 𝗺𝗮𝗻𝘂𝗮𝗹 𝗮𝗻𝗱 𝗿𝗲𝗽𝗲𝘁𝗶𝘁𝗶𝘃𝗲 𝗮𝗰𝘁𝗶𝗼𝗻𝘀.   💡 At MedBoard, we built a system to track, aggregate, and automate regulatory intelligence - so you don’t have to waste time searching and you can focus on what truly matters.   𝗪𝗶𝘁𝗵 𝗼𝘂𝗿 𝗻𝗲𝘄 𝗔𝗜 𝗔𝘀𝘀𝗶𝘀𝘁𝗮𝗻𝘁 𝘆𝗼𝘂 𝗰𝗮𝗻 𝗮𝗹𝘀𝗼: ✅ 𝗘𝘅𝘁𝗿𝗮𝗰𝘁 key information instantly from documents and news ✅ 𝗖𝗵𝗮𝘁 𝗮𝗻𝗱 𝗔𝘀𝗸 with the assistant to go deeper in the review and impact assessment ✅ Get 𝘀𝘂𝗴𝗴𝗲𝘀𝘁𝗶𝗼𝗻𝘀 for your own review framework and impact assessment process   👉 𝗪𝗶𝘁𝗵 𝗮 𝗳𝗮𝘀𝘁𝗲𝗿, 𝗺𝗼𝗿𝗲 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝘃𝗲, 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗜𝗻𝘁𝗲𝗹𝗹𝗶𝗴𝗲𝗻𝗰𝗲, 𝗿𝗲𝘃𝗶𝗲𝘄𝘀 𝗰𝗮𝗻 𝗯𝗲 𝗼𝗻 𝘁𝗶𝗺𝗲 𝗮𝗻𝗱 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝘄𝗶𝘁𝗵𝗼𝘂𝘁 𝗳𝗲𝗲𝗹𝗶𝗻𝗴 𝗼𝘃𝗲𝗿𝘄𝗵𝗲𝗹𝗺𝗲𝗱.   If you want to know more about MedBoard or try the new AI Assistant, feel free to reach out and request a free demo today!   How are you keeping up with your regulatory processes? 🚀   #MedBoard #AI #AIassistant #GenerativeAI #regulatoryintelligence #systematicreviews #impactassessment #compliance #dataextraction #medtech #pharma #compliance

🚀 𝗥𝗲𝗽𝗼𝗿𝘁 𝗔𝗻𝗮𝗹𝘆𝘁𝗶𝗰𝘀 𝗮𝘂𝘁𝗼𝗺𝗮𝘁𝗶𝗰𝗮𝗹𝗹𝘆 𝗶𝗻 𝘆𝗼𝘂𝗿 𝗟𝗶𝘁𝗲𝗿𝗮𝘁𝘂𝗿𝗲 𝗥𝗲𝘃𝗶𝗲𝘄𝘀! #WhatsNew ? Here I am today sharing with you insights on our last release on the MedBoard platform, which includes Analytics for Custom Questions and Scores within Systematic Reviews! Now available across all types of 𝗦𝘆𝘀𝘁𝗲𝗺𝗮𝘁𝗶𝗰 𝗥𝗲𝘃𝗶𝗲𝘄𝘀 💡 including 𝗟𝗶𝘁𝗲𝗿𝗮𝘁𝘂𝗿𝗲 𝗥𝗲𝘃𝗶𝗲𝘄𝘀, 𝗣𝗠𝗦 & 𝗩𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲, 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗜𝗻𝘁𝗲𝗹𝗹𝗶𝗴𝗲𝗻𝗰𝗲, 𝗠𝗮𝗿𝗸𝗲𝘁 𝗡𝗲𝘄𝘀, 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗗𝗮𝘁𝗮𝗯𝗮𝘀𝗲𝘀, and more! Our new Analytics at a glance: ✅ Dynamic counts, percentages, and charts for 𝗖𝘂𝘀𝘁𝗼𝗺 𝗤𝘂𝗲𝘀𝘁𝗶𝗼𝗻𝘀 ✅ 𝗦𝗰𝗼𝗿𝗲 distributions with interactive charts ✅ 𝗥𝗲𝗮𝗹-𝘁𝗶𝗺𝗲 𝗳𝗶𝗹𝘁𝗲𝗿𝗶𝗻𝗴: analytics update instantly as you filter your results 👉 Getting insights and reporting results based on your own review framework has never been this easy! This is just one of the many features available in the Systematic Review process on MedBoard, and we look forward to hearing your feedback on the new analytics. 💡 If you’re still using Excel sheets for your systematic reviews, start transforming your processes’ productivity and request a demo at www.medboard.com to see more. #MedBoard #WhatsNew #analytics #customanalytics #scoresanalytics #appraisals #regulatoryintelligence #systematicreviews #literaturereviews #pms #dataextraction #medtech #pharma #compliance 

EU IVDR News!! (Classification) Today (18-March) the Medical Device Coordination Group (MDCG) has released revision 4 of "MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746" This guidance addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII of Regulation (EU) 2017/746 (IVDR) Key Updates in MDCG 2020-16 rev.4: • Rule 1 (General IVDs): Clarifications for devices detecting transmissible agents. • Rule 3(m) (Companion Diagnostics): Modified footnote 8 for improved clarity. • Rule 4(a) (Self-Testing Devices): Updates to self-testing device examples. • Rule 6 (Blood, Tissue, and Organ Screening Tests): Adjustments to rationale and classification examples. • Annex 1 & 2: Editorial changes for better guidance application. The revised guidance aids manufacturers in correctly classifying their IVDs, reducing uncertainty and ensuring compliance with EU IVDR certification pathways. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence, and much more, log onto www.medboard.com or contact us at MedBoard. #IVD #MedicalDevices #RegulatoryUpdates #IVDR #MDCG #MedTech #Diagnostics #MDR #RegulatoryAffairs #Medboard #EUIVDR #Surveillance #Automation #RegulatoryIntelligence

In our Circle of Love, every day is an opportunity to celebrate our customers' success. 🫶 #TestimonialTuesday This week, we're excited to highlight TISSIUM, a MedTech company from France, revolutionizing tissue reconstruction with its biomorphic programmable polymers. Staying up-to-date on regulatory news, changes in regulations and standards was too challenging. MedBoard provided the regulatory team at TISSIUM with an all-in-one platform to manage regulatory intelligence and compliance efficiently, saving time and ensuring efficiency. “𝗪𝗲 𝗮𝗿𝗲 𝗻𝗼𝘄 𝗮𝗯𝗹𝗲 𝘁𝗼 𝗺𝗮𝗶𝗻𝘁𝗮𝗶𝗻 𝗼𝘂𝗿 𝗰𝘂𝗿𝗿𝗲𝗻𝘁 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗿𝗲𝗰𝗼𝗿𝗱𝘀, 𝗺𝗼𝗻𝗶𝘁𝗼𝗿 𝗰𝗵𝗮𝗻𝗴𝗲𝘀 𝗶𝗻 𝘁𝗵𝗼𝘀𝗲 𝗮𝗽𝗽𝗹𝗶𝗰𝗮𝗯𝗹𝗲 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀, 𝗮𝗻𝗱 𝘀𝘁𝗮𝘆 𝗮𝗯𝗿𝗲𝗮𝘀𝘁 𝗼𝗳 𝗰𝗵𝗮𝗻𝗴𝗶𝗻𝗴 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀 𝗮𝗹𝗹 𝗶𝗻 𝗼𝗻𝗲 𝗽𝗹𝗮𝗰𝗲.” - 𝘏𝘢𝘭𝘭𝘪𝘦 𝘈𝘳𝘭𝘰𝘵𝘵𝘢, 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘗𝘳𝘰𝘫𝘦𝘤𝘵 𝘔𝘢𝘯𝘢𝘨𝘦𝘳, 𝘛𝘐𝘚𝘚𝘐𝘜𝘔 A huge thank you to Hallie Arlotta, PhD and the TISSIUM team for being an integral part of our Circle of Love! ✨ “𝗔𝘀 𝗮 𝗿𝗲𝘀𝘂𝗹𝘁, 𝗼𝘂𝗿 𝗿𝗲𝘃𝗶𝗲𝘄𝘀 𝗮𝗿𝗲 𝗺𝗼𝗿𝗲 𝗲𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝘁, 𝗺𝗼𝗿𝗲 𝘁𝗿𝗮𝗻𝘀𝗽𝗮𝗿𝗲𝗻𝘁, 𝗮𝗻𝗱 𝘄𝗲 𝗰𝗮𝗻 𝗯𝗲 𝗰𝗼𝗻𝗳𝗶𝗱𝗲𝗻𝘁 𝘁𝗵𝗮𝘁 𝘄𝗲 𝗮𝗿𝗲 𝗻𝗼𝘁 𝗺𝗶𝘀𝘀𝗶𝗻𝗴 𝗮𝗻𝘆 𝗰𝗿𝘂𝗰𝗶𝗮𝗹 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻.” ✨ ✨ “𝗠𝗲𝗱𝗕𝗼𝗮𝗿𝗱 𝗵𝗮𝘀 𝗲𝘃𝗲𝗿𝘆𝘁𝗵𝗶𝗻𝗴 𝘄𝗲 𝗻𝗲𝗲𝗱 𝗶𝗻 𝗼𝗻𝗲 𝗽𝗹𝗮𝗰𝗲 𝗮𝗻𝗱 𝗶𝘀 𝗲𝗮𝘀𝘆 𝘁𝗼 𝘁𝗮𝗶𝗹𝗼𝗿 𝘁𝗼 𝘆𝗼𝘂𝗿 𝘀𝗽𝗲𝗰𝗶𝗳𝗶𝗰 𝗻𝗲𝗲𝗱𝘀.” ✨ We’re proud be part of TISSIUM’s journey and grateful to continue empowering regulatory and clinical professionals worldwide with the tools and data they need to navigate the continuously evolving regulatory landscape, ensure compliance, and massively increase their productivity. 🔍 Read the full story here: https://lnkd.in/dXZfVA5R 💡 For more customer stories and testimonials, visit: https://lnkd.in/ez-2z3fT #MedBoard #TISSIUM #TestimonialTuesday #RegulatoryIntelligence #Compliance #MedTech #MarketResearch #MarketIntelligence #Efficiency #Innovation

TGA IVD News!! (IVD Reclassification & Definition Changes) The Therapeutic Goods Administration (TGA) has launched a public consultation on proposed changes to IVD medical device classifications and definitions. The updates aim to align Australian regulations more closely with EU IVDR (Regulation 2017/746). Proposals Include: Reclassification of certain IVDs: • Cancer screening tests to re-classify as Class 3 • All devices for life-threatening diseases to re-classify as Class 3 • Adopt EU rule for newborn screening devices which will be classified as Class 3 • Control materials with assigned values to be classified as Class 3 and Class 4 Updated classification for instruments and software: • Instruments with independent measuring functions may no longer be Class 1 • Software that does not exclusively drive a device will be classified separately Alignment with EU terminology: • Adoption of certain EU definitions for improved clarity and to ensure the rules extend to new and emerging technology Transition Arrangements: A transition period is proposed for re-classification which would be six months after the current EU IVDR transition deadlines, with specific deadlines for different classes: • Class 4 IVDs: Until 30 June 2028 • Class 3 IVDs: Until 30 June 2029 • Class 2 IVDs: Until 30 June 2030 Consultation period: 12 March 2025 - 8 May 2025 Consultation link: https://lnkd.in/etPBPQ8m For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us at MedBoard. #IVD #MedicalDevices #RegulatoryUpdates #IVDR #TGAAustralia #MedTech #Diagnostics #TGA #MedicalDevices #RegulatoryAffairs #Medboard #EUIVDR #Surveillance #Automation #RegulatoryIntelligence

🚀 𝗠𝗲𝗱𝗕𝗼𝗮𝗿𝗱 𝗔𝗜 𝗔𝘀𝘀𝗶𝘀𝘁𝗮𝗻𝘁 𝗶𝗻 𝗔𝗰𝘁𝗶𝗼𝗻! 👀   Yesterday, we shared some big news, our 𝗔𝗜 𝗔𝘀𝘀𝗶𝘀𝘁𝗮𝗻𝘁 𝗶𝘀 𝗻𝗼𝘄 𝗹𝗶𝘃𝗲 𝗼𝗻 𝗠𝗲𝗱𝗕𝗼𝗮𝗿𝗱!   Today, 𝗜’𝗺 𝘀𝗵𝗼𝘄𝗶𝗻𝗴 𝘆𝗼𝘂 𝗼𝘂𝗿 𝗔𝗜 𝗔𝘀𝘀𝗶𝘀𝘁𝗮𝗻𝘁 𝗶𝗻 𝗮𝗰𝘁𝗶𝗼𝗻.   🎥 Watch the video and have a look with me on:   ✅ How the AI Assistant 𝗲𝘅𝘁𝗿𝗮𝗰𝘁𝘀 𝗸𝗲𝘆 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻 in seconds ✅ How you can 𝗮𝘀𝗸 𝗔𝗜 𝗾𝘂𝗲𝘀𝘁𝗶𝗼𝗻𝘀 𝗱𝗶𝗿𝗲𝗰𝘁𝗹𝘆 to going deeper into the extraction process ✅ How 𝗔𝗜 𝘀𝘂𝗴𝗴𝗲𝘀𝘁𝘀 𝗮𝗻𝘀𝘄𝗲𝗿𝘀 to speed up your review process   Now available across all types of 𝗦𝘆𝘀𝘁𝗲𝗺𝗮𝘁𝗶𝗰 𝗥𝗲𝘃𝗶𝗲𝘄𝘀 💡 including 𝗟𝗶𝘁𝗲𝗿𝗮𝘁𝘂𝗿𝗲 𝗥𝗲𝘃𝗶𝗲𝘄𝘀, 𝗣𝗠𝗦 & 𝗩𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲, 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗜𝗻𝘁𝗲𝗹𝗹𝗶𝗴𝗲𝗻𝗰𝗲, 𝗠𝗮𝗿𝗸𝗲𝘁 𝗡𝗲𝘄𝘀, 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗗𝗮𝘁𝗮𝗯𝗮𝘀𝗲𝘀, and more!   𝗧𝗵𝗶𝘀 𝗶𝘀 𝗷𝘂𝘀𝘁 𝘁𝗵𝗲 𝗯𝗲𝗴𝗶𝗻𝗻𝗶𝗻𝗴 of our AI journey, so stay tuned for the many new things coming!   Secure and compliant, our AI Assistant is: 🔹 𝗘𝗻𝘁𝗲𝗿𝗽𝗿𝗶𝘀𝗲-𝗴𝗿𝗮𝗱𝗲 𝘄𝗶𝘁𝗵 𝗳𝘂𝗹𝗹 𝗱𝗮𝘁𝗮 𝗰𝗼𝗻𝘁𝗿𝗼𝗹, no external APIs, our LLM runs internally for complete security 🔹 Working 𝘀𝗲𝗮𝗺𝗹𝗲𝘀𝘀𝗹𝘆 𝘄𝗶𝘁𝗵𝗶𝗻 the MedBoard 𝗽𝗹𝗮𝘁𝗳𝗼𝗿𝗺 🔹 𝗕𝘂𝗶𝗹𝘁 𝗳𝗼𝗿 𝗘𝗻𝘁𝗲𝗿𝗽𝗿𝗶𝘀𝗲𝘀, 𝗱𝗲𝘀𝗶𝗴𝗻𝗲𝗱 𝗳𝗼𝗿 𝗧𝗿𝘂𝘀𝘁. Enterprise-Ready and compliant   🔔 To know more about MedBoard or the new AI Assistant and try it, feel free to reach out or request a free demo to us! MedBoard   #MedBoard #AI #AIassistant #GenerativeAI #regulatoryintelligence #systematicreviews #literaturereviews #pms #dataextraction #medtech #pharma #compliance

EU MDR / IVDR News!! (Team-NB) Today (12-March), Team-NB has released a statement: "Certificates with Conditions – Team NB Statement." This statement clarifies the use of conditional certifications under EU MDR 2017/745 and IVDR 2017/746, outlining how notified bodies can issue certificates with specific conditions or limitations to support market access while maintaining patient safety. Key Points: • Notified bodies can issue certificates with limitations, like shortened validity periods or restrictions of sale to specific institutions with expert resources. • Conditional certificates can facilitate faster access to market for breakthrough or orphan devices, provided manufacturers meet ongoing safety and performance obligations. • This approach complements existing guidance, like MDCG 2024-10, which supports clinical evaluations for orphan devices, and aligns with recommendations from the CORE-MD project. TEAM NB therefore encourages all members in line with the CORE-MD report and in addition to point 17 on the guidance MDCG 2022-14, to continually consider the possibility of issuing certificates with specific conditions, provisions, or limitations under Annex VII section 4.8 of both the MDR and IVDR. Link CORE-MD Report on conditions on certificates by notified bodies: https://lnkd.in/eR3pFQVR For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us MedBoard. #MedicalDevices #MedTech #RegulatoryAffairs #MDR #IVDR #PostMarketSurveillance #HealthcareInnovation #NotifiedBody #NotifiedBodies #Medboard #EUIVDR #EUMDR #Surveillance #Automation #RegulatoryIntelligence

🚀 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗶𝗻𝗴 𝘁𝗵𝗲 𝗻𝗲𝘄 𝗠𝗲𝗱𝗕𝗼𝗮𝗿𝗱 𝗔𝗜 𝗔𝘀𝘀𝗶𝘀𝘁𝗮𝗻𝘁! 🚀   Our new ✨ 𝗔𝗜 𝗔𝘀𝘀𝗶𝘀𝘁𝗮𝗻𝘁 ✨ is here to transform the way you work and your productivity.   Here’s what it can do for you today: ✅ 𝗘𝘅𝘁𝗿𝗮𝗰𝘁: Instantly extract key information, overviews, and summaries from news, text and documents ✅ 𝗖𝗵𝗮𝘁 & 𝗔𝘀𝗸: Continue the extraction process by asking questions directly to the AI Assistant through the chat ✅ 𝗦𝘂𝗴𝗴𝗲𝘀𝘁: The AI Assistant will automatically suggest answers to your review questions for an even faster workflow   Now available across all types of 𝗦𝘆𝘀𝘁𝗲𝗺𝗮𝘁𝗶𝗰 𝗥𝗲𝘃𝗶𝗲𝘄𝘀 💡 including 𝗟𝗶𝘁𝗲𝗿𝗮𝘁𝘂𝗿𝗲 𝗥𝗲𝘃𝗶𝗲𝘄𝘀, 𝗣𝗠𝗦 & 𝗩𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲, 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗜𝗻𝘁𝗲𝗹𝗹𝗶𝗴𝗲𝗻𝗰𝗲, 𝗠𝗮𝗿𝗸𝗲𝘁 𝗡𝗲𝘄𝘀, 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗗𝗮𝘁𝗮𝗯𝗮𝘀𝗲𝘀, and more!   This is really just the beginning. Secure and Compliant, our AI Assistant is: 🔹 𝗘𝗻𝘁𝗲𝗿𝗽𝗿𝗶𝘀𝗲-𝗴𝗿𝗮𝗱𝗲 𝘄𝗶𝘁𝗵 𝗳𝘂𝗹𝗹 𝗱𝗮𝘁𝗮 𝗰𝗼𝗻𝘁𝗿𝗼𝗹, no external APIs, our LLM runs internally for complete security 🔹 Working 𝘀𝗲𝗮𝗺𝗹𝗲𝘀𝘀𝗹𝘆 𝘄𝗶𝘁𝗵𝗶𝗻 the MedBoard 𝗽𝗹𝗮𝘁𝗳𝗼𝗿𝗺 🔹 𝗕𝘂𝗶𝗹𝘁 𝗳𝗼𝗿 𝗘𝗻𝘁𝗲𝗿𝗽𝗿𝗶𝘀𝗲𝘀, 𝗱𝗲𝘀𝗶𝗴𝗻𝗲𝗱 𝗳𝗼𝗿 𝗧𝗿𝘂𝘀𝘁. Enterprise-Ready, and compliant   𝗦𝘁𝗮𝘆 𝘁𝘂𝗻𝗲𝗱, more AI-powered innovations are coming soon! 🚀 Interested in trying the new AI Assistant? Get in touch with us and request a free demo!   🔔 Keep following us to learn how we support Regulatory, Clinical, and Market professionals. MedBoard   #MedBoard #AI #AIassistant #GenerativeAI #regulatoryintelligence #systematicreviews #literaturereviews #pms #dataextraction #medtech #pharma #compliance 

Singapore News!! (Medical Device Cybersecurity) Today (10-March) The Health Sciences Authority (HSA) of Singapore, has released the Draft "Best Practices Guide for Medical Device Cybersecurity" for consultation. This document is to provide best practices recommendations and considerations to all medical device manufacturers and healthcare providers on general cybersecurity principles to ensure medical devices are secure throughout the Total Product Life Cycle (TPLC). Key Takeaways for Medical Device Manufacturers: • Manufacturers should integrate robust security features, conduct thorough risk assessments, and maintain a Software Bill of Materials (SBOM). • Implement systems for continuous vulnerability monitoring, timely security patches, and coordinated incident response. • Collaboration between manufacturers and healthcare providers is critical, especially during the transition to limited or end-of-support phases. • Unique risks posed by AI-driven devices (like model drift or data leaks) require additional safeguards and continuous oversight. The consultation period for this document is from 10 March 2025 to 12 May 2025. Link to consultation: https://lnkd.in/e3fPT4PV For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us at MedBoard. #MedBoard #RegulatoryIntelligence #MedicalDevices #Cybersecurity #HealthcareInnovation #MedTech #DigitalHealth #RiskManagement #HSA #RegulatoryCompliance

𝗠𝗲𝗱𝗕𝗼𝗮𝗿𝗱 𝗠𝗼𝗻𝘁𝗵𝗹𝘆 𝗣𝗠𝗦 𝗩𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲 𝗥𝗲𝗽𝗼𝗿𝘁 – 𝗙𝗲𝗯𝗿𝘂𝗮𝗿𝘆 𝟮𝟬𝟮𝟱 💡 Continuous monitoring of PMS Vigilance data and insights is essential to ensuring patient safety, product quality, and regulatory compliance. At MedBoard, 𝘄𝗲 𝘁𝗿𝗮𝗰𝗸 𝗴𝗹𝗼𝗯𝗮𝗹 𝘃𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲 𝗱𝗮𝘁𝗮 across multiple sources and authorities, ensuring you easily stay ahead on 𝘄𝗵𝗮𝘁 𝗶𝘀 𝗵𝗮𝗽𝗽𝗲𝗻𝗶𝗻𝗴 in the market, 𝗮𝗻𝘆 𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝘁𝗿𝗲𝗻𝗱, 𝗰𝗼𝗺𝗽𝗲𝘁𝗶𝘁𝗶𝗼𝗻, and 𝘀𝗶𝗺𝗶𝗹𝗮𝗿 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀. Here is the 𝗠𝗲𝗱𝗕𝗼𝗮𝗿𝗱 𝗠𝗼𝗻𝘁𝗵𝗹𝘆 𝗣𝗠𝗦 𝗩𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲 𝗥𝗲𝗽𝗼𝗿𝘁 for 𝗙𝗲𝗯𝗿𝘂𝗮𝗿𝘆 𝟮𝟬𝟮𝟱, providing: 🌍 An overview of global vigilance data and safety reports for this month 📊 Insights into FSCA, FSNs & Recall, Adverse Events, and Safety Alerts trends An analytic snapshot of some of the key PMS Vigilance data this month: 📌 𝟵𝟱𝟬+ 𝗙𝗦𝗖𝗔𝘀, 𝗙𝗦𝗡𝘀 & 𝗥𝗲𝗰𝗮𝗹𝗹𝘀 across 𝟰𝟬+ 𝗰𝗼𝘂𝗻𝘁𝗿𝗶𝗲𝘀 📌 𝟮𝟯𝟱,𝟬𝟬𝟬+ 𝗔𝗱𝘃𝗲𝗿𝘀𝗲 𝗘𝘃𝗲𝗻𝘁𝘀 reported 📌 𝟭𝟬𝟬+ 𝗦𝗮𝗳𝗲𝘁𝘆 𝗔𝗹𝗲𝗿𝘁𝘀 & 𝗖𝗼𝗺𝗺𝘂𝗻𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 from 𝟮𝟬+ 𝗰𝗼𝘂𝗻𝘁𝗿𝗶𝗲𝘀 🔍 Dive into the trends and more information, or create your systematic reviews based on your searches and scope directly in your MedBoard account! 🚀 MedBoard Global Data Access empowers Regulatory, Clinical, and Market & PMS professionals with real-time intelligence and analytics. Stay tuned for more editions! 💬 𝗪𝗲’𝗱 𝗹𝗼𝘃𝗲 𝘆𝗼𝘂𝗿 𝗶𝗻𝗽𝘂𝘁! Which insights, metrics, manufacturers, databases, are you most interested in monitoring? MedBoard One Platform, Endless Knowledge and Solutions www.medboard.com 💡 𝗥𝗲𝗾𝘂𝗲𝘀𝘁 𝗮 𝗳𝗿𝗲𝗲 𝗱𝗲𝗺𝗼 𝘁𝗼 𝗲𝘅𝗽𝗹𝗼𝗿𝗲 𝗵𝗼𝘄 𝘄𝗲 𝘀𝘂𝗽𝗽𝗼𝗿𝘁 𝘆𝗼𝘂𝗿 𝘃𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗶𝗻𝘁𝗲𝗹𝗹𝗶𝗴𝗲𝗻𝗰𝗲 𝗽𝗿𝗼𝗰𝗲𝘀𝘀𝗲𝘀. #MedBoard #PMS #Vigilance #MonthlyReport #RegulatoryIntelligence #Compliance #PatientSafety #MedTech #Pharma #LifeScience