*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.* While she has moved towards retirement since recording this video with Jaishankar Kutty, Ph.D., Nancy Morrison, RAC talks about the regulatory landmines around in the newest video in our clinical trials series. : Determining the r...
Jul 17, 2024•15 min•Transcript available on Metacast This conversation features a Q&A session with a CAPA-focused team from RQM+ and explores the unique value consultants bring to clients. Our experienced team shares their top skills, dream projects, and what drives them to make a difference in the industry. From problem-solving strategies to personal inspirations, discover how these professionals are shaping the future of medical device quality and regulatory compliance. Whether you're a professional simply interested in the field or a ma...
Jul 16, 2024•26 min•Transcript available on Metacast *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.* Combination Device Clinical Trials: Strategy & Tactics Join RQM+ experts Jaishankar Kutty, PhD and Chad Quistad as they unpack the complexities of combination device clinical trials in this comprehensive educational video. Key...
Jul 11, 2024•19 min•Transcript available on Metacast *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.* Part 2 of our key aspects of device trial design covers: Overcoming key barriers in trial design Balancing statistical significance with clinical relevance Strategies for faster enrollment and reduced dropouts Cari Kniola, Guido R...
Jul 08, 2024•13 min•Transcript available on Metacast Struggling with patient recruitment for your medical device clinical studies? Join RQM+ Clinical Trials COO David Novotny and THREAD CEO John Reites as they explore innovative hybrid study approaches to accelerate patient recruitment in MedTech research. In this conversation, you'll learn how hybrid approaches can: Expand your recruitment reach beyond geographical limitations Boost patient engagement and retention rates Save time and resources on data collection Ultimately accelerate your pr...
Jul 05, 2024•31 min•Transcript available on Metacast *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.* (/) Cari Kniola, Guido Rieger, and Jaishankar Kutty, Ph.D. return for our educational clinical trial series, this time joined by Senior Manager of Biostatistics, Rolf Hvelmann. This video covers... : Addressing and mitigating conf...
Jul 01, 2024•13 min•Transcript available on Metacast *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.* Senior Director of Clinical Operations Brandy Chittester and Senior Diretor of Project Management Cari Kniola join Jaishankar Kutty, Ph.D. to discuss... : Identifying and mitigating risks in trial design, budget, quality, timeline...
Jun 27, 2024•14 min•Transcript available on Metacast *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.* ? Securing regulatory approval is just the beginning. The newest video in our educational clinical trials series covers the intricacies of reimbursement strategy and its critical role in your product's success. Daniel Lace, MD...
Jun 25, 2024•14 min•Transcript available on Metacast *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 . Senior Project Manager Guido Rieger joins VP of Global Regulatory Affairs, Jaishankar Kutty, Ph.D. to outline: : Identifying key stakeholders Defining study en...
Jun 20, 2024•22 min•Transcript available on Metacast *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 global scale? Our latest video in the : dives deep into the best practices for pivotal studies. Join VP of Global R...
Jun 18, 2024•17 min•Transcript available on Metacast *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 first-in-human clinical studies? What ensure success?After our first two strategic videos, our educational video series on clinical trials continues with -- . Frank Maier , Director of Project Management wit...
Jun 12, 2024•12 min•Transcript available on Metacast *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 -- ? How do you manage device iterations and site selection effectively? The second video in our : -- (/) answers these questions. Once again, Jaishankar Kutty, Ph.D. ...
Jun 10, 2024•13 min•Transcript available on Metacast 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 Knowledge Center or Events pages at RQMplus.com. Thank you for tuning in. Summary The conversation discusses the pr...
Jun 07, 2024•1 hr 10 min•Transcript available on Metacast *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 -- ? What are the key considerations and best practices for manufacturers? We have answers. Here's the first video in our : -- (/). Join VP of Strategic Regulatory Affairs Sew...
Jun 05, 2024•11 min•Transcript available on Metacast . 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. : In-depth insights from industry experts Practical tips and best practices Comprehensive and interactive learning opportunities, including technical briefs, white papers, webinars, and RQM+ Live! panel discussions : Clinical trial strategy Clinical trial execution Regulatory ex...
Jun 03, 2024•2 min•Transcript available on Metacast 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 RQM+, shares his extensive industry experience and personal journey in our latest interview. ' ?...
May 08, 2024•14 min•Transcript available on Metacast 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 in. Summary In this conversation, panelists discuss the crucial role of Notified Bodies in the EU regulatory environment f...
May 01, 2024•57 min•Transcript available on Metacast 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 business and what steps you need to take to ensure compliance. - View and share this clip on LinkedIn. Follow RQM+ on LinkedI...
Apr 30, 2024•12 min•Transcript available on Metacast 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 one of Jordi's shining stars in our series: Meet Samantha Howard , Study Director! As an influential v...
Apr 29, 2024•12 min•Transcript available on Metacast 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 lifecycle: Study Start-Up : Collaborating with cross-functional teams to build user-friendly, robust datab...
Apr 19, 2024•11 min•Transcript available on Metacast 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 professional as you'llfind in regulatory affairs and as she embarks on her well-deserved retirement, she ge...
Apr 12, 2024•20 min•Transcript available on Metacast 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. Summary The conversation in this part focuses on the importance of quality systems and compliance in preventing negativ...
Apr 10, 2024•55 min•Transcript available on Metacast 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 just a single quote from this interview! Jaishankar Kutty, Ph.D. definitely helped bring out the best ...
Apr 04, 2024•15 min•Transcript available on Metacast 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: Notified body reviewers play a crucial role in the review process of clinical evaluation reports (CERs) under the...
Apr 01, 2024•13 min•Transcript available on Metacast 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 GSKto addressing ESPN's water issues, RQM+ / Jordi Labs Senior Study Director Adam Eason 's journey has shown his willingness to embrace the unknown and leverage seemingly every experience when solving complex s...
Mar 26, 2024•11 min•Transcript available on Metacast 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 that bridges gaps between data management, clinical operations, and regulatory compliance. His forward-t...
Mar 21, 2024•11 min•Transcript available on Metacast 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 Gibbsfreeenergy tattoo. As Director of Operations, she's also one of the most brilliant minds on the RQM+ Lab Services / Jordi Labs team. In this week's Excellence Spotlight interview, she shares her fascinating journe...
Mar 13, 2024•11 min•Transcript available on Metacast 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, it's time to shine the spotlight on her and only her in our newest Excellence Spotlight . A quick ...
Mar 05, 2024•11 min•Transcript available on Metacast 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 single summary report for AE data collected in PMCF studies. You'll want to watch for... Valuable...
Mar 04, 2024•9 min•Transcript available on Metacast 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 panelists discuss the requirements for claiming equivalence under the MDR and provide examples of devices that are imp...
Feb 29, 2024•59 min•Transcript available on Metacast 
