Jordi Labs, an RQM Company

Jordi Labs staff interviews continue to be shared on a weekly basis over at the RQM LinkedIn page. Please see the latest below! 👨🔬 You can also listen to these interviews on the RQM Device Advice podcast ➡️ https://lnkd.in/geUmXSct

🧪 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview series continues this week, as Christine Santagate, RAC is joined by Chemist II Michael Morales of the Jordi Labs team. 👨🔬 Discover how Michael's passion for chemistry led him to becoming a 𝘁𝗿𝘂𝗲 𝗲𝘅𝗽𝗲𝗿𝘁 𝗶𝗻 𝗴𝗮𝘀 𝗰𝗵𝗿𝗼𝗺𝗮𝘁𝗼𝗴𝗿𝗮𝗽𝗵𝘆. Michael shares: ✔️ His journey through academia and into industry ✔️ The importance of perseverance in scientific research ✔️ His experience in tackling complex projects and method development ✔️ The rewards of mentoring and giving back to the scientific community ✔️ Valuable advice for those considering a career in chemistry 🔬 Check out the interview to learn from Michael's expertise and hopefully be inspired by his enthusiasm for analytical chemistry as well! We plan to continue to highlight many more all-star employees from Jordi Labs in the coming weeks, so stay tuned. #MedTech #AnalyticalChemistry #CareerGrowth #Mentorship #JordiLabs

The RQM page will be sharing 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interviews with several Jordi Labs staff over the coming weeks. These interviews celebrate and showcase the remarkable journeys and achievements of RQM and Jordi Labs employees, and demonstrate how they are 𝗰𝗼𝗺𝗺𝗶𝘁𝘁𝗲𝗱 𝘁𝗼 𝘁𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗲𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 and 𝗺𝗮𝗸𝗲 𝗮 𝘀𝗶𝗴𝗻𝗶𝗳𝗶𝗰𝗮𝗻𝘁 𝗶𝗺𝗽𝗮𝗰𝘁 𝗼𝗻 𝗼𝘂𝗿 𝗰𝗹𝗶𝗲𝗻𝘁𝘀. We hope you enjoy. 🔬

⏳ The clock is ticking on PFAS in medical devices. 𝗔𝗿𝗲 𝘆𝗼𝘂 𝗿𝗲𝗮𝗱𝘆 𝗳𝗼𝗿 𝘄𝗵𝗮𝘁'𝘀 𝗻𝗲𝘅𝘁? Jaishankar Kutty, Ph.D., RQM VP of Global Regulatory Affairs, has written an in-depth white paper sharing the inside scoop on: 🔸 EU's REACH restriction: What it means for you 🔸 US regulations: Stay ahead of the curve 🔸 3M's PFAS exit: Your supply chain lifeline 🔸 Next-gen materials: Performance without compromise We've dropped the first four pages of the white paper below and you can follow the link to download the rest. 🔽 https://lnkd.in/gRtKwBi5 #MedTech #PFAS #MedicalDevices #RegulatoryAffairs #SupplyChain

Understand 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗰𝗵𝗲𝗺𝗶𝗰𝗮𝗹 𝗰𝗵𝗮𝗿𝗮𝗰𝘁𝗲𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 with our latest technical brief, authored by Kevin Rowland. Find insights on: 📊 ISO 10993 standards: A comprehensive overview 🧪 The ins and outs of Extractables and Leachables (E&L) testing ⚠️ Approaches to toxicological risk assessment 🔬 Understanding biological equivalence in the European Union This concise guide aims to be your go-to resource for navigating chemical characterization. We hope you'll find it both informative and practical! 🔗 https://lnkd.in/ecEBwyew We're curious: Which aspects of chemical characterization do you consider most critical in the development of medical devices? Feel free to share your thoughts in the comments below. 💬 #MedicalDevices #PatientSafety #RegulatoryCompliance #ChemicalCharacterization

Have you seen this technical brief from Vice President of Lab Services, Kaitlin Lerner? Read to explore: ⚗️ 4 key pain points of in-house chemical characterization ⚗️ How outsourcing can accelerate your product development ⚗️ The critical role of expertise in ensuring regulatory compliance #MedTech #ChemicalCharacterization #RegulatoryCompliance

This week's RQM 𝗪𝗲𝗲𝗸𝗹𝘆 𝗪𝗮𝘁𝗰𝗵 LinkedIn-exclusive newsletter includes two brand new lab-related technical briefs. 𝗧𝗵𝗿𝗲𝗲 𝗖𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗔𝘀𝗽𝗲𝗰𝘁𝘀 𝗼𝗳 𝗔𝗻𝗮𝗹𝘆𝘁𝗶𝗰𝗮𝗹 𝗧𝗲𝘀𝘁𝗶𝗻𝗴 𝗳𝗼𝗿 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹𝘀 ✍️ Authored by Kevin Rowland 🔗 https://lnkd.in/eAxrEiYX 𝗞𝗲𝘆 𝗕𝗲𝗻𝗲𝗳𝗶𝘁𝘀 𝗼𝗳 𝗖𝗵𝗲𝗺𝗶𝗰𝗮𝗹 𝗖𝗵𝗮𝗿𝗮𝗰𝘁𝗲𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗟𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝘆 𝗦𝗲𝗿𝘃𝗶𝗰𝗲𝘀 ✍️ Authored by Kaitlin Lerner 🔗 https://lnkd.in/gp_Bm82A We recommend subscribing to the RQM 𝗪𝗲𝗲𝗸𝗹𝘆 𝗪𝗮𝘁𝗰𝗵 to be sure to catch this information in the future. For example, we're planning to hold a toxicology-related panel discussion in the coming months and you can 𝘥𝘦𝘧𝘪𝘯𝘪𝘵𝘦𝘭𝘺 expect information about it in the LinkedIn newsletter. #MedTech #Pharmaceuticals #LaboratoryServices #AnalyticalTesting #ChemicalCharacterization

𝗨𝗻𝗱𝗲𝗿𝘀𝘁𝗮𝗻𝗱𝗶𝗻𝗴 𝗘𝘅𝘁𝗿𝗮𝗰𝘁𝗮𝗯𝗹𝗲𝘀 & 𝗟𝗲𝗮𝗰𝗵𝗮𝗯𝗹𝗲𝘀: 𝗪𝗵𝘆 𝗜𝘁 𝗠𝗮𝘁𝘁𝗲𝗿𝘀 [𝐣𝐮𝐬𝐭 𝐚 𝐟𝐨𝐮𝐫-𝐦𝐢𝐧𝐮𝐭𝐞 𝐫𝐞𝐚𝐝] 🏃💨 Discover how managing extractables and leachables is critical to ensuring the safety and compliance of medical devices and drug products. Our technical brief from Kevin Rowland of Jordi Labs, an RQM Company, dives into: ✨ What extractables and leachables are and why they pose risks 🔬 The importance of robust quality control and study design 📊 Key analytical techniques for detecting these potentially hazardous chemicals Equip yourself with the knowledge to 𝗽𝗿𝗼𝘁𝗲𝗰𝘁 𝗽𝗮𝘁𝗶𝗲𝗻𝘁 𝘀𝗮𝗳𝗲𝘁𝘆 𝗮𝗻𝗱 𝗺𝗮𝗶𝗻𝘁𝗮𝗶𝗻 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲. 📖 Read the brief here: https://lnkd.in/eFmT9Bra #MedTech #QualityControl #PatientSafety #RegulatoryCompliance

𝗔𝗿𝗲 𝗪𝗲 𝗘𝗾𝘂𝗶𝗽𝗽𝗲𝗱 𝘁𝗼 𝗛𝗮𝗻𝗱𝗹𝗲 𝗮 𝗣𝗙𝗔𝗦-𝗙𝗿𝗲𝗲 𝗙𝘂𝘁𝘂𝗿𝗲? 🌍 The MedTech industry faces a significant challenge: transitioning away from per- and poly-fluoroalkyl substances (PFAS). These "forever" chemicals are critical in various applications but pose substantial regulatory and supply chain issues. RQM proudly presents a comprehensive white paper by Jaishankar Kutty, Ph.D., VP of Global Regulatory Affairs, that addresses these pressing concerns. 📘 𝗥𝗲𝗮𝗱 𝘁𝗵𝗶𝘀 𝘄𝗵𝗶𝘁𝗲 𝗽𝗮𝗽𝗲𝗿 𝗳𝗼𝗿: ✓ Regulatory Insight: Understand the implications of the EU's proposed REACH restriction and the US regulatory landscape. ✓ Supply Chain Strategies: Explore solutions for the imminent challenges posed by suppliers like 3M discontinuing their PFAS portfolio. ✓ Innovation and Safety: Learn about alternative materials that maintain the integrity, safety, and performance of medical devices. 𝗦𝗲𝗲 𝗯𝗲𝗹𝗼𝘄 𝗳𝗼𝗿 𝗮 𝘀𝗻𝗲𝗮𝗸 𝗽𝗲𝗲𝗸 𝗼𝗳 𝘁𝗵𝗲 𝗳𝗶𝗿𝘀𝘁 𝗳𝗼𝘂𝗿 𝗽𝗮𝗴𝗲𝘀. 👇📄 For the complete insights and strategic approaches, download the full white paper on our website. 🔗 𝗗𝗼𝘄𝗻𝗹𝗼𝗮𝗱 𝘁𝗵𝗲 𝗪𝗵𝗶𝘁𝗲 𝗣𝗮𝗽𝗲𝗿 𝗡𝗼𝘄 https://lnkd.in/gRtKwBi5 #MedicalDevices #IVD #PFAS #Sustainability #RegulatoryAffairs #SupplyChain

We recently announced our June webinar: 𝗔𝗱𝗮𝗽𝘁𝗶𝗻𝗴 𝘁𝗼 𝘁𝗵𝗲 𝗡𝗲𝘄 𝗟𝗗𝗧 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗥𝗲𝗮𝗹𝗶𝘁𝘆 🔬 Join RQM / Jordi Labs experts Margot Borgel, Ph.D. and Bethany Knorr Chung, PhD, RAC as they discuss the FDA's Final Rule on LDTs. 📅 Date: June 20th, 2024 ⏰ Time: 11:00 AM EST Key Topics: ✔️ Expanded enforcement discretion for LDTs ✔️ Phased implementation and compliance milestones ✔️ LDTs classified as medical devices ✔️ Compliance strategies for labs Who Should Attend: ✔️ Lab Managers, ✔️ QA/Regulatory Affairs Professionals ✔️ Product Development Teams 🔗 Reserve your spot here https://lnkd.in/evhsMigu