Making MedTech Happen with RQM+

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠⁠⁠ reach out to RQM+ ⁠⁠⁠ if you need support with clinical trials.* 🌍 Our educational video series on clinical trials continues today with 𝗧𝗮𝗰𝘁𝗶𝗰𝘀 𝗳𝗼𝗿 𝗚𝗹𝗼𝗯𝗮𝗹 𝗣𝗶𝘃𝗼𝘁𝗮𝗹 𝗦𝘁𝘂𝗱𝗶𝗲𝘀. Senior Project...

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠⁠ reach out to RQM+ ⁠⁠ if you need support with clinical trials.* 🔍 Strategy for Global Pivotal Studies 🌍 Ever wondered what it takes to ensure the success of your clinical trials on a glo...

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠⁠ reach out to RQM+ ⁠⁠ if you need support with clinical trials.* ❓ How do you effectively 𝗲𝘅𝗲𝗰𝘂𝘁𝗲 first-in-human clinical studies? ❓ What 𝘁𝗮𝗰𝘁𝗶𝗰𝗮𝗹 𝘀𝘁𝗲𝗽𝘀 ensure success? After our first tw...

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠ reach out to RQM+ ⁠ if you need support with clinical trials.* ❓ What are the CGMP principles and traceability requirements for 𝗳𝗶𝗿𝘀𝘁-𝗶𝗻-𝗵𝘂𝗺𝗮𝗻 𝘀𝘁𝘂𝗱𝗶𝗲𝘀? How do you manage device iterations...

This was recorded 6 June 2024. We encourage you to download the presentation slides by ⁠⁠⁠ completing the form on this page ⁠⁠⁠ . Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the ⁠⁠⁠⁠ Kn...

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* ❓ What are the objectives and benefits of conducting 𝗳𝗶𝗿𝘀𝘁-𝗶𝗻-𝗵𝘂𝗺𝗮𝗻 𝘀𝘁𝘂𝗱𝗶𝗲𝘀? What are the key considerations and best practices f...

🎓 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗶𝗻𝗴 𝗼𝘂𝗿 𝗻𝗲𝘄 𝗲𝗱𝘂𝗰𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝘃𝗶𝗱𝗲𝗼 𝘀𝗲𝗿𝗶𝗲𝘀 𝗼𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀. Our VP of Global Regulatory Affairs, Jaishankar Kutty, Ph. D. , welcomes you to a free series designed to share our wealth of knowledge and best practices in clinical trial strategy, execution, and regulatory expertise. 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 𝗼𝗳 𝘁𝗵𝗶𝘀 𝘀𝗲𝗿𝗶𝗲𝘀: ✨ In-depth insights from industry experts 🛠️ Practical tips and best practices 📄 Co...

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. "Encouraging and driving a strong culture of quality allows a company to effectively manage the details in a collaborative way." Scott Edwards , Managing Director at...

This show was recorded 25 April 2024. We encourage you to download the IVDR timeline presented at the beginning of this session by ⁠⁠ completing the form on this page ⁠⁠ . Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the ⁠⁠⁠ Knowledge Center ⁠⁠⁠ or ⁠⁠⁠ Events ⁠⁠⁠ pages at RQMplus.com. Thank you for tuning...

𝗡𝗘𝗪𝗦 → FDA releases final rule on Laboratory-Developed Tests (LDTs) 🚨 RQM+'s Bethany Knorr Chung, PhD, RAC and Margot Borgel, Ph. D. dive into the details of what you need to know, including: ✅ The 4-year phase-in timeline for compliance ✅ Expanded enforcement discretion for certain LDTs ✅ Grandfathering clause for currently marketed LDTs Watch now to learn how this rule impacts your busin...

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🔬 Hot on the heels of  Jordi Labs ' groundbreaking new publication support for simulated use testing of blood-contacting medical devices, we're thrilled to showcase on...

In this special bonus clip from our Excellence Spotlight series, Sr. Director of Data Operations (Clinical Trials)  Noel Keegan  takes a deep dive into clinical data management. From the transition to electronic systems to the exciting potential of AI, Noel reflects on the evolution he's witnessed over his 16+ year career. He breaks down the key aspects of data management across the study life...

While we believe you will find Nancy's story and advice inspiring without visuals, we encourage you to watch the video version containing a brief presentation on the RQM+ website here . In this heartfelt and insightful video presentation, now available on our blog, Nancy Morrison, RAC shares her journey and the lessons she's learned along the way. Nancy is as highly a respected professiona...

This show was recorded 28 March 2024. We encourage you to download the presentation given in the first portion of this session by ⁠ completing the form on this page ⁠ . Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the ⁠⁠ Knowledge Center ⁠⁠ or ⁠⁠ Events ⁠⁠ pages at RQMplus.com. Thank you for tuning in. 🙏...

Our Excellence Spotlight interview series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. These employees are committed to technical excellence and make significant positive contributions to our clients' success. In our newest interview, we're thrilled to showcase Vice President of Strategic Regulatory Affairs, Dr.  Sew-Wah Tay . It was tough to share j...

RQM+  Vice President of Global Regulatory Affairs (and former BSI),  Jaishankar Kutty, Ph. D. , discusses the process of reviewing clinical evaluation reports (CERs) by notified body reviewers under the EU MDR in our newest video clip. In the end and more than anything, manufacturers must provide a clear and comprehensive story in their CERs to facilitate the review process. 📖 Highlights: Notifie...

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧪 With a fascinating career spanning drug development with GSK to addressing ESPN's water issues, RQM+ /  Jordi Labs  Senior Study Director  Adam Eason 's journey has...

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. Our newest Excellence Spotlight interview is with  Noel Keegan , a central figure in RQM+ clinical trial services. Noel is Sr. Director of Data Operations and has expertise tha...

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🔬  Kaitlin Lerner  is "that chemist" with a Gibbs free energy tattoo. As Director of Operations, she's also one of the most brilliant minds on the RQM+ Lab Servi...

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. Yesterday, we published a clip of RQM+ Senior Consultant  Anastassia Young, MS  discussing our recent conversation with the  FDA  related to Adverse Event (AE) Reporting. Today...

Are you navigating adverse event (AE) reporting in post-market clinical follow-up (PMCF) studies? In a recent discussion with the  FDA , we've uncovered valuable insights into exemptions and variances for AE reporting that could significantly reduce your reporting burden . This collaboration between RQM+ and the FDA paves the way for a more efficient process , allowing for the submission of a...

This show was recorded 22 February 2024. We encourage you to download the supplemental PDF content for this session by completing the form on this page . Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the ⁠ Knowledge Center ⁠ or ⁠ Events ⁠ pages at RQMplus.com. Thank you for tuning in. 🙏 Summary The panelis...

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🌌 Meet the supremely talented  Song Seto, PhD, RAC  in our latest Excellence Spotlight interview. Song is a Principal in our RA/QA practice. With a rich background from  Unive...

Summary This discussion provides a high-level overview of the current state of artificial intelligence (AI) in in vitro diagnostics (IVDs). The conversation between Director of IVD Intelligence and Innovation, Margot Borgel, and Principal Regulatory Scientist, Bethany Chung, Ph. D., RAC, covers several aspects of AI in IVDs, including its use in diagnosis and predictive algorithms, aiding in the d...

Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🔬 Meet RQM+ Director of Biological Evaluation Consulting,  Taryn Meade , in our latest Excellence Spotlight interview! Jaishankar Kutty, Ph. D.  describes her as "elegant...