Jordi Labs, an RQM+ Company’s Post

🔄 Major changes are coming to 𝗜𝗦𝗢 𝟭𝟬𝟵𝟵𝟯-𝟭 that will transform how MedTech manufacturers approach biological evaluation. Is your team ready? Join premier experts from Jordi Labs, an RQM+ Company for an essential conversation exploring the new ISO 10993-1 risk management framework. Attendees will leave with practical strategies to... ✓ 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗲 𝘁𝗵𝗲 𝗶𝗻𝘁𝗲𝗴𝗿𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗜𝗦𝗢 𝟭𝟰𝟵𝟳𝟭 𝗽𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀 𝗶𝗻𝘁𝗼 𝘆𝗼𝘂𝗿 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗰𝗲𝘀𝘀 ✓ 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁 𝗻𝗲𝘄 𝗿𝗶𝘀𝗸 𝗲𝘀𝘁𝗶𝗺𝗮𝘁𝗶𝗼𝗻 𝗮𝗽𝗽𝗿𝗼𝗮𝗰𝗵𝗲𝘀 𝘁𝗵𝗮𝘁 𝗮𝗹𝗶𝗴𝗻 𝘄𝗶𝘁𝗵 𝗰𝗼𝗺𝗶𝗻𝗴 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 ✓ 𝗔𝗱𝗮𝗽𝘁 𝘆𝗼𝘂𝗿 𝗱𝗲𝘃𝗶𝗰𝗲 𝗰𝗮𝘁𝗲𝗴𝗼𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗺𝗲𝘁𝗵𝗼𝗱𝘀 𝘁𝗼 𝗮𝗰𝗰𝗼𝘂𝗻𝘁 𝗳𝗼𝗿 𝗺𝗼𝗱𝗶𝗳𝗶𝗲𝗱 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗲𝗳𝗳𝗲𝗰𝘁𝘀 ✓ 𝗠𝗮𝗶𝗻𝘁𝗮𝗶𝗻 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗱𝘂𝗿𝗶𝗻𝗴 𝘁𝗵𝗶𝘀 𝘀𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻 Featured experts: Taryn Meade – Director of Biological Evaluation Stephen Bond – Senior Toxicologist Amanda DeGraw, MS, PhD, DABT – Principal Toxicologist Moderated by Christine Santagate, RAC – VP of Lab Services 🗓️ November 21, 2024 ⏰ 11am ET / 5pm CEST 📝 Certificate of Participation available for live attendees Don't miss this chance to get ahead of what's being called "one of the major changes in the standard." Your proactive participation today will help ensure your submissions succeed tomorrow. ✍ https://lnkd.in/eJrjxKND #MedTech #RegulatoryCompliance #MedicalDevices #ISO10993 #BiologicalEvaluation #QualityManagement

Take the opportunity to ask the experts for QC recommendations and the best way to manage quality in your lab. Learn about the importance of quality control in the lab, with real life examples from the experts and tips for managing your data to help your clinical decision-making needs.

The #MDCG 2024-12 has been released to provide guidance to #conformityassessment bodies, #notifiedbodies, designating authorities, and Joint Assessment Teams involved in the implementation of #MDR and #IVDR on how to establish corrective action and preventive action plan assessments. TheGuidance covers: 📌CAPA Templates 👉Annex I: Template for documenting CAPA plans. 👉Annex II: Template for Joint Assessment Team (JAT) review. 📌 Root Cause Analysis with a focus on investigating and addressing systemic issues and not only symptoms. 📌 Corrective & Preventive Actions and how to design them to prevent future non-compliances and risks. 📌Verification of Effectiveness with a focus on how to use SMART criteria to ensure the effectiveness of corrective actions. 📄 Annex I: https://lnkd.in/dqpSHe3u 📄 Annex II: https://lnkd.in/dttuCT2d #medtechnews #medicaldevices #biotechnews #medtech #biotech #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #cemark #cemarking #EVNIA_AR #Evnia_UKPR #CAPA #QualityManagement

𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐭𝐡𝐞 𝐅𝐃𝐀’𝐬 𝐍𝐞𝐰 𝐋𝐃𝐓 𝐑𝐮𝐥𝐞: 𝐀𝐧 𝐀𝐩𝐩𝐫𝐨𝐚𝐜𝐡 𝐟𝐨𝐫 𝐌𝐨𝐥𝐞𝐜𝐮𝐥𝐚𝐫 𝐋𝐚𝐛𝐬 The recent FDA regulation on Laboratory Developed Tests (LDTs) has sent ripples through the molecular lab community. Compliance is crucial to avoid hefty fines and operational disruptions. In our latest blog, we dive into strategies to mitigate risks and ensure your lab stays ahead of the curve. 🔍 𝐻𝑖𝑔ℎ𝑙𝑖𝑔ℎ𝑡𝑠 𝑖𝑛𝑐𝑙𝑢𝑑𝑒: - Ensuring test accuracy and reliability - Implementing comprehensive quality control - Keeping meticulous records and reports 💡 𝐾𝑒𝑦 𝑆𝑡𝑟𝑎𝑡𝑒𝑔𝑖𝑒𝑠: - Strengthen Quality Management Systems - Enhance Staff Training - Invest in Advanced Technology - Engage with Regulatory Experts - Focus on Risk Management Working on a proactive plan to prepare your lab for this new regulation? 👉 Read the full blog: https://lnkd.in/gFiySYgd #ldtrule #fda #molecularlabs #diagnostics #novopath

🔍𝐒𝐢𝐦𝐩𝐥𝐢𝐟𝐲𝐢𝐧𝐠 𝐎𝐄𝐂𝐃 𝐆𝐋𝐏 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐰𝐢𝐭𝐡 𝐛𝐢𝐨𝐦𝐞𝐝𝐢𝐨𝐧🔍 Navigating the OECD guidelines on Good Laboratory Practice (GLP) and Compliance Monitoring (ENV/CBC/MONO(2021)26) can be complex. If compliance feels overwhelming, you’re not alone—and we’re here to help! At biomedion, we’ve broken down the principles into an easy-to-follow whitepaper to guide your GLP compliance journey. ✨ See how neuronOS is built to support your GLP compliance needs—today and for the future. 📥 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐲𝐨𝐮𝐫 𝐜𝐨𝐦𝐩𝐫𝐞𝐡𝐞𝐧𝐬𝐢𝐯𝐞 𝐰𝐡𝐢𝐭𝐞𝐩𝐚𝐩𝐞𝐫 𝐡𝐞𝐫𝐞: https://lnkd.in/dPfXdgQb Stay ahead with biomedion's expertise and neuronOS’s forward-thinking solutions. #OECD #LifeSciences #GLP #Compliance #DataIntegrity #biomedion #neuronOS #DataManagement

I recommend our latest white paper for anyone facing the challenges of OECD GLP compliance. Clear guidance, practical insights. Download it here. 📥 #OECD #GLP #Compliance #DataIntegrity #biomedion #neuronOS

Did you miss our recent webinar "Good Laboratory Practices (GLP) Regulations: Introduction and Strategies for Implementation" with Jaclyn Bellomo and Cynthia Weber? Learn about the requirements of 21 CFR 58, Good Laboratory Practices for Nonclinical Studies and valuable examples of why GLP is important in a lab setting while identifying if the regulation applies to you and your company. This webinar will also identify key strategies for implementation and how to maintain compliance. Watch the recording on your own time: https://hubs.li/Q02LmksF0 #CosmeticsIndustry #MoCRA #MoCRACompliance #GLP #RegistrarCorp #FreeWebinar

Join us for our free webinar, “Good Laboratory Practices (GLP) Regulations: Introduction and Strategies for Implementation” tomorrow at 1PM ET with Jaclyn Bellomo and Cynthia Weber. Learn about the requirements of 21 CFR 58, Good Laboratory Practices for Nonclinical Studies and valuable examples of why GLP is important in a lab setting while identifying if the regulation applies to you and your company. This webinar will also identify key strategies for implementation and how to maintain compliance! Register Now: https://hubs.li/Q02KNsnX0 #CosmeticsIndustry #MoCRA #MoCRACompliance #GLP #RegistrarCorp #FreeWebinar

In a recent LinkedIn survey, 60% of respondents identified Quality/Regulatory Compliance as their lab's biggest challenge. This is no surprise, given the numerous changes this year. At the end of December 2023, CLIA published its most significant revision since its inception in 1988. Additionally, after nearly 30 years of anticipation, the FDA issued a final rule on regulating LDTs, which goes into effect next month. The first deliverables are due in May 2025, with additional requirements each May until 2028. Furthermore, the FDA has announced the harmonization of the Quality System Requirements with the ISO 13485 standard. These regulatory changes have raised many questions and concerns for labs. At Omics Lab Solutions, we specialize in helping labs navigate these complexities. Whether achieving compliance with the new CLIA requirements or aligning with ISO 13485 standards, our expertise ensures your lab remains compliant and efficient. Let's discuss how your lab is handling these regulatory changes and share best practices. Comment below or reach out to me directly to learn how we can support you.

📑 Mastering the Biological Evaluation Report (BER) for Medical Devices [Blog post 👉 https://lnkd.in/ddYyii4t] The Biological Evaluation Report (BER) is a key document that showcases the safety of your medical device and aids in securing regulatory approval. Our latest article delves into the essentials of creating a comprehensive BER that meets international standards and regulatory expectations. 🔍 What You’ll Learn: 👉 Understanding the BER: Why it’s crucial for regulatory submissions. 👉 ISO 10993 Compliance: How to align your BER with global standards. 👉 Steps for Success: From planning and data analysis to risk assessment and expert review. 👉 Overcoming Challenges: Tips for handling incomplete data and regulatory compliance issues. Ensure your BER stands out by integrating these best practices and insights. Read the full article here: https://lnkd.in/ddYyii4t ______________________________________ #MedicalDevices #BiologicalEvaluation #RegulatoryCompliance #ISO10993 #BER #FDA #EU_MDR #QualityAssurance #RiskManagement