Jordi Labs, an RQM+ Company

🧪 𝗦𝗮𝗹𝗲𝘀 𝗠𝗲𝗲𝘁𝘀 𝗦𝗰𝗶𝗲𝗻𝗰𝗲. 𝗔𝗽𝗽𝗹𝘆 𝗬𝗼𝘂𝗿 𝗖𝗵𝗲𝗺𝗶𝘀𝘁𝗿𝘆 𝗘𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲 𝗜𝗻 𝗡𝗲𝘄 𝗪𝗮𝘆𝘀. Are you ready to bring your expertise in chemistry into the fast-moving world of #MedTech? At RQM+, we’re looking for an 𝗜𝗻𝘀𝗶𝗱𝗲 𝗦𝗮𝗹𝗲𝘀 𝗥𝗲𝗽𝗿𝗲𝘀𝗲𝗻𝘁𝗮𝘁𝗶𝘃𝗲 (𝗖𝗵𝗲𝗺𝗶𝘀𝘁𝗿𝘆 𝗕𝗮𝗰𝗸𝗴𝗿𝗼𝘂𝗻𝗱) to join our commercial team and play a key role in connecting life-changing innovations with the people who need them most. 𝗜𝗻 𝘁𝗵𝗶𝘀 𝗿𝗼𝗹𝗲, 𝘆𝗼𝘂’𝗹𝗹: 🌟 Combine your love for science with strategic sales outreach 🌟 Qualify leads, build relationships, and offer tailored solutions 🌟 Collaborate with a world-class team to drive meaningful results This isn’t just another sales role. It’s your opportunity to make a tangible difference in healthcare while advancing your career in an exciting and supportive environment. 📍 Remote opportunity, US-based 👉 𝗔𝗽𝗽𝗹𝘆 and grow with us in 2025: https://lnkd.in/eMW8v9sm

🌀 Rewinding to November's panel discussion on critical shifts in biological evaluation – 𝘯𝘰𝘸 𝘢𝘷𝘢𝘪𝘭𝘢𝘣𝘭𝘦 𝘰𝘯 𝘥𝘦𝘮𝘢𝘯𝘥 – Jordi Labs, an RQM+ Company Director of Biological Evaluation Taryn Meade offers a high-level overview of the looming changes to ISO 10993-1. For full details and what you can expect to get out of watching or listening to the session, follow the link in the comments. #BiologicalEvaluation #ISO10993 #MedicalDevices

📢 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

𝗔𝗻 𝗢𝘃𝗲𝗿𝘃𝗶𝗲𝘄 𝗼𝗳 𝗖𝗵𝗲𝗺𝗶𝗰𝗮𝗹 𝗖𝗵𝗮𝗿𝗮𝗰𝘁𝗲𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 Explore the intricacies of medical device materials in this technical brief by EVP & GM of Jordi Labs, Kevin Rowland. You'll learn why why robust chemical characterization is vital for patient safety and regulatory compliance. 🧪 ISO 10993 Standards: Ensuring biocompatibility and safe use. 🔍 Extractables & Leachables: Identifying potential risks. ⚠️ Toxicological Risk Assessment: From hazard to risk characterization. 🧬 Biological Equivalence: Leveraging existing data for new devices. Navigate the complexities of chemical characterization to enhance device reliability and efficacy. Read the full technical brief to understand how RQM+ can guide you through these critical processes. 🔗 https://lnkd.in/ecEBwyew

💡 "𝘛𝘩𝘦 𝘪𝘯𝘵𝘦𝘯𝘵𝘪𝘰𝘯 𝘪𝘴 𝘯𝘰𝘵 𝘵𝘰 𝘥𝘳𝘪𝘷𝘦 𝘢 𝘸𝘩𝘰𝘭𝘦 𝘣𝘪𝘨 𝘳𝘦𝘦𝘷𝘢𝘭𝘶𝘢𝘵𝘪𝘰𝘯 𝘧𝘰𝘳 𝘦𝘷𝘦𝘳𝘺𝘵𝘩𝘪𝘯𝘨 𝘵𝘩𝘢𝘵 𝘪𝘴 𝘢𝘭𝘳𝘦𝘢𝘥𝘺 𝘢𝘱𝘱𝘳𝘰𝘷𝘦𝘥 𝘢𝘯𝘥 𝘤𝘶𝘳𝘳𝘦𝘯𝘵𝘭𝘺 𝘶𝘴𝘦𝘥." – Taryn Meade As #MedTech braces for significant updates to ISO 10993-1, concerns about the impact on existing devices are at the forefront. In yesterday's RQM+ Live! panel discussion, Jordi Labs, an RQM+ Company experts addressed many of the anxieties we've heard about from clients head-on. Dive into the full on-demand discussion to learn: ✅ The most critical changes to ISO 10993-1 and their implementation timeline ✅ How to integrate the ISO 14971 risk management framework into biological evaluation ✅ Strategic considerations for compliance during the transition 🎥 Watch on-demand: https://lnkd.in/eJrjxKND #ISO10993 #BiologicalEvaluation #RiskManagement #Toxicology

Prepare for ISO 10993-1 updates with insights from leading toxicologists. 𝗝𝗼𝗶𝗻 𝘂𝘀 𝗧𝗵𝘂𝗿𝘀𝗱𝗮𝘆 𝗳𝗼𝗿 𝗥𝗤𝗠+ 𝗟𝗶𝘃𝗲! 🎙️ Top-tier experts from Jordi Labs, an RQM+ Company (full panel listed below) will discuss the upcoming revisions to ISO 10993-1 and their implications for biological evaluation processes. 𝘐𝘧 𝘺𝘰𝘶’𝘳𝘦 𝘪𝘯 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘢𝘧𝘧𝘢𝘪𝘳𝘴, 𝘲𝘶𝘢𝘭𝘪𝘵𝘺 𝘮𝘢𝘯𝘢𝘨𝘦𝘮𝘦𝘯𝘵, 𝘙&𝘋, 𝘰𝘳 𝘢 𝘳𝘰𝘭𝘦 𝘪𝘯 𝘥𝘦𝘷𝘪𝘤𝘦 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘮𝘦𝘯𝘵, 𝘵𝘩𝘪𝘴 𝘴𝘦𝘴𝘴𝘪𝘰𝘯 𝘪𝘴 𝘢 𝘧𝘪𝘵 𝘧𝘰𝘳 𝘺𝘰𝘶! Meet the panelists: Taryn Meade – Director of Biological Evaluation Stephen Bond – Senior Toxicologist Amanda DeGraw, MS, PhD, DABT – Principal Toxicologist Christine Santagate, RAC – VP of Lab Services (Moderator) Can’t make it live? No problem—register to receive the recording and a timestamped summary. Link below!   📅 Date: Thursday, 21 November 🕘 Time: 11:00am ET | 5:00pm CEST 👩💻 Secure Your Spot for the Panel > https://lnkd.in/eJrjxKND

Jordi Labs, an RQM+ Company's Taryn Meade leads an exciting and accomplished group of panelists in next week's RQM+ Live! panel discussion — 𝗖𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗦𝗵𝗶𝗳𝘁𝘀 𝗶𝗻 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻: Inside the New ISO 10993-1 Risk Management Framework Learn more and sign up for the event here ➡️ https://lnkd.in/eJrjxKND #BiologicalEvaluation #RegulatoryAffairs #MedTech

🔄 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

Yesterday over at the RQM+ page, we announced a new lab-focused panel discussion – 𝗖𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗦𝗵𝗶𝗳𝘁𝘀 𝗶𝗻 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻: 𝗜𝗻𝘀𝗶𝗱𝗲 𝘁𝗵𝗲 𝗡𝗲𝘄 𝗜𝗦𝗢 𝟭𝟬𝟵𝟵𝟯-𝟭 𝗥𝗶𝘀𝗸 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗙𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸. 🥼 𝗔𝘁𝘁𝗲𝗻𝗱𝗲𝗲𝘀 𝘄𝗶𝗹𝗹: ✔️ Master the new ISO 14971 framework application to biological evaluation ✔️ Understand critical updates to device categorization ✔️ Get ahead of changes before they take effect ✔️ Learn implementation strategies for maintaining compliance 𝗝𝗼𝗿𝗱𝗶 𝗟𝗮𝗯𝘀 𝗽𝗮𝗻𝗲𝗹𝗶𝘀𝘁𝘀 𝗮𝗻𝗱 𝗺𝗼𝗱𝗲𝗿𝗮𝘁𝗼𝗿: – Taryn Meade, Director of Biological Evaluation – Stephen Bond, Senior Toxicologist – Amanda DeGraw, MS, PhD, DABT, Principal Toxicologist – Christine Santagate, RAC, VP of Lab Services (Moderator) 🧪 The special event is on 𝙏𝙝𝙪𝙧𝙨𝙙𝙖𝙮, 𝙉𝙤𝙫𝙚𝙢𝙗𝙚𝙧 21𝙨𝙩 and you can sign up here: https://lnkd.in/eJrjxKND #MedTech #ISO10993 #BiologicalEvaluation #RegulatoryAffairs #MedicalDevices #QualityManagement #RiskManagement

Director of IVD Global Regulatory Affairs, Margot Borgel, Ph.D., answers seven of the biggest questions about #LDTs right now in a brand new technical brief. When will we have an answer about the lawsuit❓ What happens if ACLA/AMP win their lawsuit❓ What happens if FDA wins their lawsuit❓ What if the lawsuit isn’t resolved before May 6, 2025 or the decision is appealed❓ What about the election❓ Will we see the return of the VALID act❓ and, of course... 𝗪𝗵𝗮𝘁 𝘀𝗵𝗼𝘂𝗹𝗱 𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝗶𝗲𝘀 𝗯𝗲 𝗱𝗼𝗶𝗻𝗴❓ 🔗 https://lnkd.in/eMmM8inx #MedTech #IVDs #LabTesting #Diagnostics #RegulatoryAffairs