Absolutely incredible discussion during RQM+ Live! today. ๐ฅ 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. โ๏ธ ๐ https://lnkd.in/eU-Mka5P In the words of attendees... ๐ฌ "๐๐ถ๐ต๐ด๐ต๐ข๐ฏ๐ฅ๐ช๐ฏ๐จ ๐ข๐ด ๐ข๐ญ๐ธ๐ข๐บ๐ด ๐ข๐ฏ๐ฅ ๐จ๐ณ๐ฆ๐ข๐ต ๐ฑ๐ณ๐ฆ๐ด๐ฆ๐ฏ๐ต๐ฆ๐ณ๐ด / ๐ฑ๐ข๐ฏ๐ฆ๐ญ ๐ฅ๐ช๐ด๐ค๐ถ๐ด๐ด๐ช๐ฐ๐ฏ ๐ฐ๐ฏ ๐ข ๐ฌ๐ฆ๐บ ๐ณ๐ฆ๐ญ๐ฆ๐ท๐ข๐ฏ๐ต ๐ต๐ฐ๐ฑ๐ช๐ค." ๐ฌ "๐๐ฉ๐ข๐ฏ๐ฌ๐ด ๐ง๐ฐ๐ณ ๐ด๐ฉ๐ข๐ณ๐ช๐ฏ๐จ ๐บ๐ฐ๐ถ๐ณ ๐ช๐ฏ๐ด๐ช๐จ๐ฉ๐ต๐ด, ๐ฎ๐ข๐ฌ๐ฆ๐ด ๐ช๐ต ๐ฎ๐ฐ๐ณ๐ฆ ๐ณ๐ฆ๐ข๐ญ!" ๐ฌ "๐๐ฐ๐ถ๐ฏ๐ฅ ๐ต๐ฉ๐ฆ ๐ธ๐ฆ๐ฃ๐ช๐ฏ๐ข๐ณ ๐ณ๐ฆ๐ข๐ญ๐ญ๐บ ๐ถ๐ด๐ฆ๐ง๐ถ๐ญ ๐ข๐ด ๐ฃ๐ข๐ด๐ฆ๐ฅ ๐ฐ๐ฏ ๐ค๐ถ๐ณ๐ณ๐ฆ๐ฏ๐ต ๐ฅ๐ฆ๐ท๐ฆ๐ญ๐ฐ๐ฑ๐ฎ๐ฆ๐ฏ๐ต๐ด ๐ณ๐ข๐ต๐ฉ๐ฆ๐ณ ๐ต๐ฉ๐ข๐ฏ ๐ข๐ฏ ๐ช๐ฏ๐ต๐ณ๐ฐ ๐ต๐ฐ ๐ฅ๐ฆ๐ท๐ช๐ค๐ฆ ๐ณ๐ฆ๐ฒ๐ถ๐ช๐ณ๐ฆ๐ฎ๐ฆ๐ฏ๐ต๐ด." ๐ฌ "๐๐ฐ๐ท๐ฆ๐ฅ ๐ต๐ฉ๐ฆ ๐ฅ๐ช๐ด๐ค๐ถ๐ด๐ด๐ช๐ฐ๐ฏ ๐ง๐ฐ๐ณ๐ฎ๐ข๐ต." Here's an excerpt from Edward B. that articulates the complexities and ambiguities manufacturers face. #MedTech #EUMDR #IVDR #RegulatoryAffairs #SupplyChain
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๐งช Our ๐๐ ๐ฐ๐ฒ๐น๐น๐ฒ๐ป๐ฐ๐ฒ ๐ฆ๐ฝ๐ผ๐๐น๐ถ๐ด๐ต๐ interview series continues this week, as Christine Santagate, RAC is joined by Lab Coordinator Craig Young of the Jordi Labs team. ๐จ๐ฌ Discover how Craig's diverse background in chemistry and project management led him to become an ๐ฒ๐๐๐ฒ๐ป๐๐ถ๐ฎ๐น ๐ฝ๐ฎ๐ฟ๐ ๐ผ๐ณ ๐ผ๐๐ฟ ๐ผ๐ฝ๐ฒ๐ฟ๐ฎ๐๐ถ๐ผ๐ป๐. Craig shares: โ๏ธ His journey from WPI to Las Vegas and back to Mansfield โ๏ธ Experiences in biodiesel production and laboratory startups โ๏ธ How his "jack-of-all-trades" nature suits lab coordination โ๏ธ His role in implementing ClickUp for project management โ๏ธ Valuable advice for those entering the scientific industry โ๏ธ We'll be continuing to highlight more Jordi Labs all-star team members in the coming weeks, so stay tuned. #MedTech #AnalyticalChemistry #CareerGrowth #ProjectManagement #JordiLabs
Craig Young, Lab Coordinator (Jordi Labs) | Excellence Spotlight
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๐ฃ๏ธ Looking for some conversation starters at this week's Regulatory Affairs Professionals Society (RAPS) Convergence in Long Beach, California? The latest ๐ฅ๐ค๐ + ๐ช๐ฒ๐ฒ๐ธ๐น๐ ๐ช๐ฎ๐๐ฐ๐ต is now available. ๐ฐ The ๐ฅ๐ค๐ + ๐ช๐ฒ๐ฒ๐ธ๐น๐ ๐ช๐ฎ๐๐ฐ๐ต is our LinkedIn-exclusive newsletter helping #MedTech professionals stay informed of the week prior's most important regulatory and industry updates. Read the latest below. ๐ฐ #MedTech #MedicalDevices #RegulatoryAffairs #HealthcareInnovation #RAPS
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The calm waters before the regulatory ๐ at this yearโs Regulatory Affairs Professionals Society (RAPS) Convergence in Long Beach, California. If youโre attending, we hope youโll add our brochure to your registration bag assembly. ๐ โ ๐๏ธ #RegulatoryAffairs #MedTech #MedicalDevices #IVDs #RAPS2024
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๐ฆ๐ผ... who's in California this week?! ๐โ๏ธ ๐โ๏ธ It's time for Regulatory Affairs Professionals Society (RAPS)' annual Convergence in the United States and here are all the ways you can find RQM+ in Long Beach. โฌ๏ธ [Already underway!] ๐ฆ๐๐ฟ๐๐ถ๐๐ผ๐ฟ: ๐ง๐ต๐ฒ ๐๐๐ ๐ฑ๐ญ๐ฌ(๐ธ) ๐ฃ๐ฟ๐ผ๐ด๐ฟ๐ฎ๐บ ๐๐ฑ๐ถ๐๐ถ๐ผ๐ป (๐ฃ๐ฟ๐ฒ-๐๐ผ๐ป๐ณ๐ฒ๐ฟ๐ฒ๐ป๐ฐ๐ฒ ๐ช๐ผ๐ฟ๐ธ๐๐ต๐ผ๐ฝ) (16-17 Sept. | 8:30 AM โ 4:00 PM PDT) โ 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. ๐ฃ๐น๐ฒ๐ป๐ฎ๐ฟ๐ ๐ฆ๐ฒ๐๐๐ถ๐ผ๐ป: ๐๐ต๐ฎ๐น๐น๐ฒ๐ป๐ด๐ฒ๐ ๐ถ๐ป ๐๐ฒ๐๐ฒ๐น๐ผ๐ฝ๐ถ๐ป๐ด ๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐ง๐ฒ๐ฐ๐ต๐ป๐ผ๐น๐ผ๐ด๐ถ๐ฒ๐ ๐ณ๐ผ๐ฟ ๐จ๐ป๐บ๐ฒ๐ ๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐ก๐ฒ๐ฒ๐ฑ๐ (Wednesday, 18 Sept. |ย 8:15 AM โ 9:00 AM PDT) โ Allison Komiyama, PhD, RAC is a panelist, along with Cheryl Coon, Karl-Heinz Huemer, and Justin West, MD. Joรฃo Duarte will moderate the group. ๐๐ฒ๐๐ฒ๐ฟ๐ฎ๐ด๐ถ๐ป๐ด ๐ง๐ฒ๐ฐ๐ต๐ป๐ผ๐น๐ผ๐ด๐ ๐ฎ๐ป๐ฑ ๐ฆ๐บ๐ฎ๐ฟ๐ ๐ง๐ฒ๐บ๐ฝ๐น๐ฎ๐๐ฒ๐ ๐๐ผ ๐ข๐ฝ๐๐ถ๐บ๐ถ๐๐ฒ ๐๐จ ๐ ๐๐ฅ ๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐๐๐ฎ๐น๐๐ฎ๐๐ถ๐ผ๐ป ๐ฎ๐ป๐ฑ ๐ฃ๐ผ๐๐-๐ ๐ฎ๐ฟ๐ธ๐ฒ๐ ๐ฆ๐๐ฟ๐๐ฒ๐ถ๐น๐น๐ฎ๐ป๐ฐ๐ฒ ๐๐ผ๐ฐ๐๐บ๐ฒ๐ป๐๐ฎ๐๐ถ๐ผ๐ป (Wednesday, 18 Sept. | 12:25 PM โ 12:50 PM PDT) โ RQM+ Vice President of Technical, Jonathan Gimbel, will present, and will be joined by Fern.ai Product Manager Sara Contu, MSc. ๐๐ ๐ต๐ถ๐ฏ๐ถ๐ ๐๐ฎ๐น๐น, ๐๐ผ๐ผ๐๐ต #๐ญ๐ฌ๐ญ๐ณ โ We hope you'll stop by our booth! We're looking forward to catching up with friends, both old and new. We have a raffle you won't want to miss as well! (hint: โ) #RAPS2024 #MedTech #RAPSConvergence2024 #RegulatoryAffairs #MedicalDevices
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๐งช Our ๐๐ ๐ฐ๐ฒ๐น๐น๐ฒ๐ป๐ฐ๐ฒ ๐ฆ๐ฝ๐ผ๐๐น๐ถ๐ด๐ต๐ interview series continues this week, as Christine Santagate, RAC is joined by Chemist II Michael Morales of the Jordi Labs team. ๐จ๐ฌ Discover how Michael's passion for chemistry led him to becoming a ๐๐ฟ๐๐ฒ ๐ฒ๐ ๐ฝ๐ฒ๐ฟ๐ ๐ถ๐ป ๐ด๐ฎ๐ ๐ฐ๐ต๐ฟ๐ผ๐บ๐ฎ๐๐ผ๐ด๐ฟ๐ฎ๐ฝ๐ต๐. Michael shares: โ๏ธ His journey through academia and into industry โ๏ธ The importance of perseverance in scientific research โ๏ธ His experience in tackling complex projects and method development โ๏ธ The rewards of mentoring and giving back to the scientific community โ๏ธ Valuable advice for those considering a career in chemistry ๐ฌ 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
Michael Morales, Chemist II (Jordi Labs) | Excellence Spotlight
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Last call for today's RQM+ Live! panel discussion โย ๐ ๐๐ฅ ๐ฎ๐ป๐ฑ ๐๐ฉ๐๐ฅ ๐๐บ๐ฒ๐ป๐ฑ๐บ๐ฒ๐ป๐๐: ๐ฆ๐๐ฟ๐ฎ๐๐ฒ๐ด๐ถ๐ฒ๐ ๐ณ๐ผ๐ฟ ๐ฆ๐๐ฝ๐ฝ๐น๐ ๐๐ป๐๐ฒ๐ฟ๐ฟ๐๐ฝ๐๐ถ๐ผ๐ป ๐๐ผ๐บ๐ฝ๐น๐ถ๐ฎ๐ป๐ฐ๐ฒ. Don't miss leading edge insights (truly!) from our panelists, including three guests: โข Erik Vollebregt โ Advocaat, Axon Lawyers โข Heike Moehlig-Zuttermeister โ Global Director IVD, TรV SรD โข Donielle Johnson โ Global Regulatory Affairs Executive โข Edward B. โ Manager, Intelligence & Strategic Execution, RQM+ โข Amie Smirthwaite, PhD, FRAPS โ 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. ๐ฏ๏ธ๐ญ https://lnkd.in/eU-Mka5P #MedTech #EUMDR #IVDR #MedicalDevices
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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 ๐ฐ๐ฟ๐ถ๐๐ถ๐ฐ๐ฎ๐น ๐ฟ๐ผ๐น๐ฒ ๐ผ๐ณ ๐๐ฅ๐ข๐ ๐ถ๐ป ๐ฑ๐ฎ๐๐ฎ ๐บ๐ฎ๐ป๐ฎ๐ด๐ฒ๐บ๐ฒ๐ป๐. Noel covers: ๐ค The importance of partnership between CROs and sponsors ๐ Key performance and quality indicators across all trial phases ๐ Independent quality review processes ๐ Leveraging standardized libraries and best practices ๐ฏ 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
How a CRO Helps with Data Management In Clinical Trials โ MedTech CRO: Clinical Trial Execution Series
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๐ก Access curated #MedTech industry articles and more in the newest ๐ฅ๐ค๐ + ๐ช๐ฒ๐ฒ๐ธ๐น๐ ๐ช๐ฎ๐๐ฐ๐ต newsletter. This week's edition has arrived. #MedTech #MedicalDevices #RegulatoryAffairs #HealthcareInnovation
RQM+ Weekly Watch #25
RQM+ on LinkedIn
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๐ด RQM+ will be an Innovator Sponsor at Regulatory Affairs Professionals Society (RAPS) Convergence 2024ย in Long Beach, California next week! ย 4๏ธโฃ ๐๐ฎ๐๐ ๐๐ผ ๐ณ๐ถ๐ป๐ฑ ๐๐ ๐๐ต๐ฒ๐ฟ๐ฒ: ๐ฆ๐๐ฟ๐๐ถ๐๐ผ๐ฟ: ๐ง๐ต๐ฒ ๐๐๐ ๐ฑ๐ญ๐ฌ(๐ธ) ๐ฃ๐ฟ๐ผ๐ด๐ฟ๐ฎ๐บ ๐๐ฑ๐ถ๐๐ถ๐ผ๐ป (๐ฃ๐ฟ๐ฒ-๐๐ผ๐ป๐ณ๐ฒ๐ฟ๐ฒ๐ป๐ฐ๐ฒ ๐ช๐ผ๐ฟ๐ธ๐๐ต๐ผ๐ฝ) (16-17 Sept. | 8:30 AM โ 4:00 PM PDT) โ 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 ๐ฃ๐น๐ฒ๐ป๐ฎ๐ฟ๐ ๐ฆ๐ฒ๐๐๐ถ๐ผ๐ป: ๐๐ต๐ฎ๐น๐น๐ฒ๐ป๐ด๐ฒ๐ ๐ถ๐ป ๐๐ฒ๐๐ฒ๐น๐ผ๐ฝ๐ถ๐ป๐ด ๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐ง๐ฒ๐ฐ๐ต๐ป๐ผ๐น๐ผ๐ด๐ถ๐ฒ๐ ๐ณ๐ผ๐ฟ ๐จ๐ป๐บ๐ฒ๐ ๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐ก๐ฒ๐ฒ๐ฑ๐ (Wednesday, 18 Sept. |ย 8:15 AM โ 9:00 AM PDT) โ Allison Komiyama, PhD, RAC is a panelist, along with Cheryl Coon, Karl-Heinz Huemer, and Justin West, MD. Joรฃo Duarte will moderate. ๐๐ฒ๐๐ฒ๐ฟ๐ฎ๐ด๐ถ๐ป๐ด ๐ง๐ฒ๐ฐ๐ต๐ป๐ผ๐น๐ผ๐ด๐ ๐ฎ๐ป๐ฑ ๐ฆ๐บ๐ฎ๐ฟ๐ ๐ง๐ฒ๐บ๐ฝ๐น๐ฎ๐๐ฒ๐ ๐๐ผ ๐ข๐ฝ๐๐ถ๐บ๐ถ๐๐ฒ ๐๐จ ๐ ๐๐ฅ ๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐๐๐ฎ๐น๐๐ฎ๐๐ถ๐ผ๐ป ๐ฎ๐ป๐ฑ ๐ฃ๐ผ๐๐-๐ ๐ฎ๐ฟ๐ธ๐ฒ๐ ๐ฆ๐๐ฟ๐๐ฒ๐ถ๐น๐น๐ฎ๐ป๐ฐ๐ฒ ๐๐ผ๐ฐ๐๐บ๐ฒ๐ป๐๐ฎ๐๐ถ๐ผ๐ป (Wednesday, 18 Sept. | 12:25 PM โ 12:50 PM PDT) โ RQM+ Vice President of Technical, Jonathan Gimbel, will present, and will be joined by Fern.ai Product Manager Sara Contu, MSc. ๐๐ ๐ต๐ถ๐ฏ๐ถ๐ ๐๐ฎ๐น๐น, ๐๐ผ๐ผ๐๐ต #๐ญ๐ฌ๐ญ๐ณ โ If you're attending, please stop by!ย We can't wait to meet and catch up with attendees in person. You can enter for a chance to win a โ, too. #MedTech #RAPSConvergence2024 #RegulatoryAffairs #MedicalDevices
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Manager, Regulatory Affairs-Edwards Lifesciences
5dThe discussion was highly informative and insightful. A follow-up session could be valuable to address the audience's many unanswered questions. All speakers demonstrated deep expertise, and Erik's funny yet engaging style was the highlight of this discussion.