Making MedTech Happen with RQM+

📢 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 form...

🏥 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...

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 Garre...

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 n...

💬 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 b...

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. H...

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 Documenta...

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...

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...

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 forthc...

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 spi...

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...

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...

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. Clinica...

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 nav...

🚨 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 d...

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...

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...

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 proudly features our Director of Global Audit Practice, Dr. Richard Freeman . Richard's journey from academia to industry has made him a...

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. ➕ In today's 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁, we're extremely excited to feature Senior Consultant  Andrew Lakey , Ph. D. Andrew is a multidisciplinary scientist whose career spa...

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. 💬 "Stay ready so you don't have to get ready." –  Brandy Chittester , Senior Director of Clinical Operations In a new Excellence Spotlight interview, we're t...

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 Excellence Spotlight series proudly showcases the technical excellence personified by our team. Senior Principal Engineer,  Hrishikesh Gadagkar , Ph. D., stands as a par...

🎥  Sally Sennitt  and  Jaishankar Kutty, Ph. D.  are starting off this week with plenty of good things to say in a new MedTech Voices video. This time, they unpack the EU MDR expert panel's evaluation of a novel resorbable device aimed at revolutionizing hernia repair procedures. Why watch (or listen) 👇 🔍 Scrutinizing the Longevity of Resorbable Devices: Understand the balance between durab...

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 Senior Director of Project Management  Cari Kniola  in our newest Excellence Spotlight interview 👇 Cari navigates clinical trials with expertise and commitment. Her 26...

This show was recorded 26 October 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 ⁠⁠⁠⁠⁠⁠⁠⁠⁠ . Thank you for tuning in! 🙏 Listen in as Boston Scientific's Sr. Global Regulatory Intelligence & Advocacy Manager joined RQM+ experts for a special editi...