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...
Apr 10, 2024•55 min
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
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 ...
Apr 01, 2024•13 min
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 shown his willingness to embrace the unknown and leverage seemingly every experience when solving compl...
Mar 26, 2024•11 min
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
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 Services / Jordi Labs team. In this week's Excellence Spotlight interview, she shares her fascinating j...
Mar 13, 2024•11 min
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 qui...
Mar 05, 2024•11 min
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... Valua...
Mar 04, 2024•9 min
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 t...
Feb 29, 2024•59 min
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 University of California, Berkeley and Georgia Institute of Technology , as well as experience as a lead rev...
Feb 27, 2024•9 min
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 diagnostic workflow, supporting performance testing, and assisting in regulatory efforts. The importan...
Feb 20, 2024•33 min
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, talented, quietly confident, and always understated," but we're not going to be understated ...
Feb 19, 2024•13 min
📢 Hear Jaishankar Kutty, Ph.D. 's four-minute summary on MDCG 2023-7 and how you can benefit from attending next week's RQM+ Live! panel discussion: New Clinical Evidence Pathways for Legacy and New Devices . 🎟️ RSVP for the 22 February event here. Why are we talking about this? To address and clarify potential misinterpretations of Article 61, Items 4, 5, and 6, highlighted by the formation of an MDCG task force. End goal of next week's panel? To answer audience questions and prov...
Feb 15, 2024•4 min
🏥 In connection with the FDA ’s recent approval of Edwards Lifesciences ’ transcatheter tricuspid valve replacement device, here is some commentary from RQM+ Vice President of Intelligence & Innovation, Jaishankar Kutty, Ph.D. , about the importance of the benefit-risk story within the target patient population under the aegis of the state of the art and standard of care, in justifying the quantity of clinical data. Jai also discusses certain aspects of uncertainty that will face other foll...
Feb 14, 2024•14 min
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. From bioengineering student at the University of Pittsburgh to PMCF study leader, meet Garrett Jeffries, PhD in our newest Excellence Spotlight interview. A snapshot of Garrett’s background and impact to RQM+ clients: 🔬 Bioengineering Brilliance : Garrett has built a career ...
Feb 13, 2024•14 min
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. 📜 Elizabeth Starling went from law school aspirations to becoming a force in regulatory affairs and clinical research as a Senior Consultant at RQM+. Hear her story in our newest Excellence Spotlight interview. Just a snippet of what sets Elizabeth apart: 🧠 Deep Regulatory ...
Feb 06, 2024•13 min
💬 New MedTech Voices Episode: Sally Sennitt and Jaishankar Kutty, Ph.D. dissect the expert panel's review of a groundbreaking extravascular implantable cardiac defibrillator (ICD) and offer insights into regulatory challenges and cardiac care innovation. Takeaways: 👇 Expert Review Insights for a Novel Extravascular ICD : Get an insider's perspective on the stringent review process by the EU expert panel, including the critical evaluation of safety, efficacy, and novel features of the d...
Feb 05, 2024•15 min
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. 🌟 A seasoned expert in global regulatory affairs and project management, Senior Manager Laurie Pettit, PMP shares her journey in our newest Excellence Spotlight interview. Here's why Laurie is an invaluable asset to RQM+ and our clients: 🌍 Global Regulatory Savvy : From...
Jan 30, 2024•13 min
MedTech Moments are a curated selection of the most impactful snippets from our expert panel discussions. This clip was taken from RQM+ Live! #72 – EU MDR Timelines and Fine Lines: Unraveling Critical Transition Nuances to Gain Compliance . What makes a good EU MDR program from a maintenance perspective? We answered this question in RQM+ Live! #72, featuring: Sharmila Gardner – Technical Documentation Manager & Head of UK Approved Body, Intertek Brian Dahl – Vice President of Quality and Reg...
Jan 29, 2024•10 min
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 Nicholas Wilson , Ph.D. – Principal, Clinical and Post-Market Practice – in our new Excellence Spotlight interview. What makes Nicholas special? A lot! Please listen to his story in the interview, but here are just a few reasons RQM+ clients love working with Nicholas: �...
Jan 26, 2024•15 min
Have you seen the proposed amendments to MDR and IVDR published this week? Margot Borgel, Ph.D. and Jaishankar Kutty, Ph.D. sat down to discuss the details of this proposal, the potential impacts to manufacturers, and some questions and concerns surrounding this proposal. All current transition timelines have been extended by 2.5 years with new deadlines ranging from 31 December 2027 for highest risk devices to 31 December 2029 for the lower risk devices. There are some conditions around these t...
Jan 24, 2024•15 min
This show was recorded 18 January 2024. Download the slides from this presentation (including bonus slides not presented) by submitting 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. 🙏 Brief With the forthcoming restrictions on Per- and Polyfluoroalkyl Substances (PFAS), medical device manufacturers are o...
Jan 22, 2024•1 hr 24 min
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. 2️⃣ things we're excited about today... 1. Our new Excellence Spotlight interview featuring RQM+ Senior Principal and former FDA-er Alexia Haralambous – a mastermind in spinal devices and global regulatory affairs. 2. Alexia has just been added as a panelist to next week&...
Jan 10, 2024•15 min
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. 🎆 Happy new year! We're bringing the most positive energy we can to start 2024 with a heartwarming and uplifting RQM+ Excellence Spotlight interview with Niki Caporali Spaniel, RAC . Niki's journey blends a deep-seated passion for healthcare with an extremely impress...
Jan 02, 2024•14 min
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. 🎄 This week's Excellence Spotlight shines on a standout member of our clinical and post-market team, Senior Consultant / Capability Manager, Lindsay Wright . A snapshot of what Lindsay brings to RQM+ and our clients 👇 Biomedical Engineering and Mechanical Engineering In...
Dec 20, 2023•13 min
After a lull which has now picked up with FDA approvals, what's next for renal denervation? RQM+ VP of Intelligence and Innovation Jaishankar Kutty, Ph.D. shares the knowns and unknowns in a new video clip. 📝 Quick summary Renal denervation is a technology that aims to control blood pressure by disrupting renal nerve activity through a minimally invasive, irreversible procedure. Clinical trial data is mixed, with modest reductions in blood pressure observed. Skepticism and uncertainties sur...
Dec 19, 2023•11 min
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. ➕ Today's Excellence Spotlight features Principal RA/QA Rostislav Stoykov . With a strong foundation in biomedical and clinical engineering, Rostislav has masterfully navigated the complex regulatory landscape and made significant contributions in the medical device indus...
Dec 12, 2023•15 min
🚨 Hear Jaishankar Kutty, Ph.D. discuss the critical impact of PFAS phase-out on medical device manufacturing and then, 🎟️ RSVP to our January 2024 event for exclusive downloadable content. We hope you find Jai's commentary to be an excellent summary of the topic! Our January presentation and panel, Exiting PFAS: A Strategic Blueprint for Medical Device Manufacturers , will go significantly deeper, providing proactive strategies to navigate this major shift. A few quick takeaways from Jai&#...
Dec 11, 2023•9 min
This show was recorded 30 November 2023 and can be viewed on our website here . To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our Knowledge Center . We have a ton of on-demand content there, too. Thank you for tuning in! 🙏 Takeaways LDTs have historically been subject to enforcement discretion by the FDA, but as they have become more complex and used in higher-risk settings, the FDA is proposing regula...
Dec 05, 2023•54 min
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. ➕ The plus is the people at RQM+ and today's Excellence Spotlight features Torrie DeGennaro , a star in biomedical engineering and quality assurance at RQM+. Torrie's innovative approach to PMCF data collection has been pivotal in securing MDR certification for numero...
Dec 04, 2023•10 min
