RQM+

Absolutely incredible discussion during RQM+ Live! today. 🔥 If you missed it, our team was joined by Erik Vollebregt, Heike Moehlig-Zuttermeister, and Donielle Johnson to discuss the latest MDR and IVDR amendments. The short presentation and panel discussion are now available on demand. ↙️ 🔗 https://lnkd.in/eU-Mka5P In the words of attendees... 💬 "𝘖𝘶𝘵𝘴𝘵𝘢𝘯𝘥𝘪𝘯𝘨 𝘢𝘴 𝘢𝘭𝘸𝘢𝘺𝘴 𝘢𝘯𝘥 𝘨𝘳𝘦𝘢𝘵 𝘱𝘳𝘦𝘴𝘦𝘯𝘵𝘦𝘳𝘴 / 𝘱𝘢𝘯𝘦𝘭 𝘥𝘪𝘴𝘤𝘶𝘴𝘴𝘪𝘰𝘯 𝘰𝘯 𝘢 𝘬𝘦𝘺 𝘳𝘦𝘭𝘦𝘷𝘢𝘯𝘵 𝘵𝘰𝘱𝘪𝘤." 💬 "𝘛𝘩𝘢𝘯𝘬𝘴 𝘧𝘰𝘳 𝘴𝘩𝘢𝘳𝘪𝘯𝘨 𝘺𝘰𝘶𝘳 𝘪𝘯𝘴𝘪𝘨𝘩𝘵𝘴, 𝘮𝘢𝘬𝘦𝘴 𝘪𝘵 𝘮𝘰𝘳𝘦 𝘳𝘦𝘢𝘭!" 💬 "𝘍𝘰𝘶𝘯𝘥 𝘵𝘩𝘦 𝘸𝘦𝘣𝘪𝘯𝘢𝘳 𝘳𝘦𝘢𝘭𝘭𝘺 𝘶𝘴𝘦𝘧𝘶𝘭 𝘢𝘴 𝘣𝘢𝘴𝘦𝘥 𝘰𝘯 𝘤𝘶𝘳𝘳𝘦𝘯𝘵 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘮𝘦𝘯𝘵𝘴 𝘳𝘢𝘵𝘩𝘦𝘳 𝘵𝘩𝘢𝘯 𝘢𝘯 𝘪𝘯𝘵𝘳𝘰 𝘵𝘰 𝘥𝘦𝘷𝘪𝘤𝘦 𝘳𝘦𝘲𝘶𝘪𝘳𝘦𝘮𝘦𝘯𝘵𝘴." 💬 "𝘓𝘰𝘷𝘦𝘥 𝘵𝘩𝘦 𝘥𝘪𝘴𝘤𝘶𝘴𝘴𝘪𝘰𝘯 𝘧𝘰𝘳𝘮𝘢𝘵." Here's an excerpt from Edward B. that articulates the complexities and ambiguities manufacturers face. #MedTech #EUMDR #IVDR #RegulatoryAffairs #SupplyChain

🧪 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

Last call for today's RQM+ Live! panel discussion – 𝗠𝗗𝗥 𝗮𝗻𝗱 𝗜𝗩𝗗𝗥 𝗔𝗺𝗲𝗻𝗱𝗺𝗲𝗻𝘁𝘀: 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗲𝘀 𝗳𝗼𝗿 𝗦𝘂𝗽𝗽𝗹𝘆 𝗜𝗻𝘁𝗲𝗿𝗿𝘂𝗽𝘁𝗶𝗼𝗻 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲. Don't miss leading edge insights (truly!) from our panelists, including three guests: • Erik Vollebregt – Advocaat, Axon Lawyers • Heike Moehlig-Zuttermeister – Global Director IVD, TÜV SÜD • Donielle Johnson – Global Regulatory Affairs Executive • Edward B. – Manager, Intelligence & Strategic Execution, RQM+ • Amie Smirthwaite, PhD, FRAPS – Senior VP, Scientific Affairs, RQM+ (moderator) If you can't make the session at 11am ET / 5pm CEST today, we encourage you to sign up anyway to receive the presentation (there will be some slides), recording, and summary of topics covered with timestamps. 🗯️💭 https://lnkd.in/eU-Mka5P #MedTech #EUMDR #IVDR #MedicalDevices

In our third and final clinical trials video focused on data management, Senior Director of Data Operations Noel Keegan returns to speak with Jaishankar Kutty, Ph.D. about the 𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗿𝗼𝗹𝗲 𝗼𝗳 𝗖𝗥𝗢𝘀 𝗶𝗻 𝗱𝗮𝘁𝗮 𝗺𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁. Noel covers: 🤝 The importance of partnership between CROs and sponsors 🏆 Key performance and quality indicators across all trial phases 🔍 Independent quality review processes 📚 Leveraging standardized libraries and best practices 🎯 Tailoring services to meet specific sponsor needs In the end, a CRO should act as an extension of the sponsor's team, providing expertise, accountability, and flexibility throughout the clinical trial process. #MedTech #ClinicalTrials #DataManagement #CRO #RegulatoryAffairs

💡 Access curated #MedTech industry articles and more in the newest 𝗥𝗤𝗠+ 𝗪𝗲𝗲𝗸𝗹𝘆 𝗪𝗮𝘁𝗰𝗵 newsletter. This week's edition has arrived. #MedTech #MedicalDevices #RegulatoryAffairs #HealthcareInnovation

🌴 RQM+ will be an Innovator Sponsor at Regulatory Affairs Professionals Society (RAPS) Convergence 2024 in Long Beach, California next week!   4️⃣ 𝘄𝗮𝘆𝘀 𝘁𝗼 𝗳𝗶𝗻𝗱 𝘂𝘀 𝘁𝗵𝗲𝗿𝗲: 𝗦𝘂𝗿𝘃𝗶𝘃𝗼𝗿: 𝗧𝗵𝗲 𝗙𝗗𝗔 𝟱𝟭𝟬(𝗸) 𝗣𝗿𝗼𝗴𝗿𝗮𝗺 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 (𝗣𝗿𝗲-𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝗪𝗼𝗿𝗸𝘀𝗵𝗼𝗽) (16-17 Sept. | 8:30 AM – 4:00 PM PDT) ↘ RQM+ VP of MedTech Innovations, Allison Komiyama, PhD, RAC, is one of the instructors. She joins Mark DuVal, J.D. FRAPS, Lisa Pritchard, Kathy Herzog, Dongbo Wang, and FDA/CDRH Deputy Ombudsman Ken Skodacek 𝗣𝗹𝗲𝗻𝗮𝗿𝘆 𝗦𝗲𝘀𝘀𝗶𝗼𝗻: 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗶𝗻 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗶𝗻𝗴 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗲𝘀 𝗳𝗼𝗿 𝗨𝗻𝗺𝗲𝘁 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗡𝗲𝗲𝗱𝘀 (Wednesday, 18 Sept. | 8:15 AM – 9:00 AM PDT) ↘ Allison Komiyama, PhD, RAC is a panelist, along with Cheryl Coon, Karl-Heinz Huemer, and Justin West, MD. João Duarte will moderate. 𝗟𝗲𝘃𝗲𝗿𝗮𝗴𝗶𝗻𝗴 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆 𝗮𝗻𝗱 𝗦𝗺𝗮𝗿𝘁 𝗧𝗲𝗺𝗽𝗹𝗮𝘁𝗲𝘀 𝘁𝗼 𝗢𝗽𝘁𝗶𝗺𝗶𝘇𝗲 𝗘𝗨 𝗠𝗗𝗥 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗣𝗼𝘀𝘁-𝗠𝗮𝗿𝗸𝗲𝘁 𝗦𝘂𝗿𝘃𝗲𝗶𝗹𝗹𝗮𝗻𝗰𝗲 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 (Wednesday, 18 Sept. | 12:25 PM – 12:50 PM PDT) ↘ RQM+ Vice President of Technical, Jonathan Gimbel, will present, and will be joined by Fern.ai Product Manager Sara Contu, MSc. 𝗘𝘅𝗵𝗶𝗯𝗶𝘁 𝗛𝗮𝗹𝗹, 𝗕𝗼𝗼𝘁𝗵 #𝟭𝟬𝟭𝟳 ↘ If you're attending, please stop by! We can't wait to meet and catch up with attendees in person. You can enter for a chance to win a ⌚, too. #MedTech #RAPSConvergence2024 #RegulatoryAffairs #MedicalDevices

Donielle Johnson joins RQM+ Live! 𝙏𝙃𝙄𝙎 𝙏𝙃𝙐𝙍𝙎𝘿𝘼𝙔 as a guest panelist for... 🥁🥁🥁 𝗠𝗗𝗥 𝗮𝗻𝗱 𝗜𝗩𝗗𝗥 𝗔𝗺𝗲𝗻𝗱𝗺𝗲𝗻𝘁𝘀: 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗲𝘀 𝗳𝗼𝗿 𝗦𝘂𝗽𝗽𝗹𝘆 𝗜𝗻𝘁𝗲𝗿𝗿𝘂𝗽𝘁𝗶𝗼𝗻 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 Donielle joins Heike Moehlig-Zuttermeister of TÜV SÜD, Erik Vollebregt of Axon Lawyers, and Edward B. and Amie Smirthwaite, PhD, FRAPS of RQM+, to discuss the implications for manufacturers due to the #MDR and #IVDR amendments and share 𝘢𝘤𝘵𝘪𝘰𝘯𝘢𝘣𝘭𝘦 strategies to ensure compliance. The session is designed for: • Regulatory affairs and quality assurance pros • Operations management • Production planning and supply chain managers, and... • Just about anyone responsible for MDR and IVDR requirements! Secure 𝗬𝗢𝗨𝗥 spot by signing up here 👉 https://lnkd.in/eU-Mka5P 𝘊𝘢𝘯'𝘵 𝘫𝘰𝘪𝘯 12 𝘚𝘦𝘱𝘵𝘦𝘮𝘣𝘦𝘳? 𝘕𝘰 𝘴𝘸𝘦𝘢𝘵 – 𝘱𝘭𝘦𝘢𝘴𝘦 𝘳𝘦𝘨𝘪𝘴𝘵𝘦𝘳 𝘢𝘯𝘺𝘸𝘢𝘺, 𝘢𝘯𝘥 𝘸𝘦'𝘭𝘭 𝘴𝘦𝘯𝘥 𝘺𝘰𝘶 𝘵𝘩𝘦 𝘳𝘦𝘤𝘰𝘳𝘥𝘪𝘯𝘨 𝘢𝘯𝘥 𝘢 𝘴𝘶𝘮𝘮𝘢𝘳𝘺 𝘸𝘪𝘵𝘩 𝘵𝘪𝘮𝘦𝘴𝘵𝘢𝘮𝘱𝘴.

📢 We've been shouting from the rooftops about our guest panelists for next week's RQM+ Live! show regarding the MDR and IVDR amendments, but RQM+ Manager of Intelligence and Strategic Execution, Edward B., will be a panelist, too. In late July, Ed wrote 𝗧𝗵𝗿𝗲𝗲 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗣𝗿𝗶𝗰𝗲 𝗼𝗳 𝗢𝗻𝗲: 𝗧𝗵𝗲 𝗟𝗮𝘁𝗲𝘀𝘁 𝗔𝗺𝗲𝗻𝗱𝗺𝗲𝗻𝘁𝘀 𝘁𝗼 𝘁𝗵𝗲 𝗠𝗗𝗥 & 𝗜𝗩𝗗𝗥 𝗛𝗮𝘃𝗲 𝗔𝗿𝗿𝗶𝘃𝗲𝗱. Three tables from his technical brief can be seen below. 📄 Read the brief: https://lnkd.in/g72eCRdk 🎙️ Save your spot for next week's panel: https://lnkd.in/eU-Mka5P #MedTech #EUMDR #IVDR

🛑 Is your #MedTech company ready for potential supply chain disruptions in Europe stemming from the recent MDR and IVDR amendments? Take our quick poll, then join our live panel on 12 September featuring experts from Axon Lawyers and notified body TÜV SÜD. 👉 Event details and registration in comments below #EUMDR #IVDR

👨🔬 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 short interview series continues this week, as Christine Santagate, RAC is joined by another member of the Jordi Labs team, Tommy Kumlin. See how Tommy's background in chemistry and chemical engineering led him to become a jack-of-all-trades in analytical techniques. 🔬 Tommy shares: ✔️ His specialization in spectroscopy, microscopy, and thermal analysis ✔️ How he combines different techniques for comprehensive analysis ✔️ The satisfaction of instrument troubleshooting and maintenance ✔️ The importance of collaboration in a professional environment ✔️ Valuable advice for those entering the industry Stay tuned as we plan to highlight additional Jordi Labs staff in the coming weeks! 🧫 #ThePlusIsThePeople #MedTech #AnalyticalChemistry #CareerGrowth #Collaboration