🚨 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's cli...
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 numerous legac...
Dec 04, 2023•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. ➕ 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 standout expert in product development, process development, and quality systems, to name just a few. Highli...
Nov 29, 2023•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. ➕ In today's 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁, we're extremely excited to feature Senior Consultant Andrew Lakey , Ph.D. Andrew is a multidisciplinary scientist whose career spans academia, industry, and notified body experience, making him a vital asset to our IVD tea...
Nov 21, 2023•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. 💬 "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 thrilled to talk with Brandy Chittester , a key figure in clinical research at RQM+. Brandy skillfully bridges the gap b...
Nov 15, 2023•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. 🎙️ Our Excellence Spotlight series proudly showcases the technical excellence personified by our team. Senior Principal Engineer, Hrishikesh Gadagkar , Ph.D., stands as a paramount example of this dedication. Three highlights from our newest interview: 🛤️ Tech Trailblazer i...
Nov 07, 2023•15 min
🎥 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 durability and resorption rates in implantable devices and why this matters for patient outcomes. 🌐 Exploring the...
Nov 06, 2023•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. ➕ Meet Senior Director of Project Management Cari Kniola in our newest Excellence Spotlight interview 👇 Cari navigates clinical trials with expertise and commitment. Her 26+ years of experience in clinical research elevates the capacity of RQM+ to serve clients and drive inn...
Nov 01, 2023•15 min
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 edition of our Live! show, all about the month's industry events! This session brings together insights from ...
Oct 27, 2023•1 hr 3 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 Excellence Spotlight series and host Jaishankar Kutty, Ph.D. are back this week with a feature on RQM+ Senior Project Manager, Ethan Elshoff, MPH, MBA . Three standout points from the interview: 📊 Mastery in Business Analytics and Healthcare Strategy : Ethan possesse...
Oct 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 we're shining the spotlight on Principal Consultant Dr. Catherine Kang ! We love this interview and hope you'll listen. With an engineering foundation, deep roots in biomaterials, cell biology, and tissue engineering, Catherine's expertise doesn't stop there. She stands...
Oct 10, 2023•14 min
🎥 Sally Sennitt and Jaishankar Kutty, Ph.D. are back and looking into the expert panel's insights on a shoulder replacement system; a device that has the potential to redefine orthopedic solutions. Why you should watch 👇 📘 Deep Understanding of Clinical Evidence: Dive into the intricacies of what constitutes 'sufficient' clinical data and why it's paramount in regulatory processes. ⚙️ Beyond the Basics: Learn about the multiple facets and variables of shoulder replacement, its implications, a...
Oct 05, 2023•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. Meet RQM+ Director of R&D (and "detective" 🕵️) Kevin Rowland in our new Excellence Spotlight ... 🔍 Two highlights about Kevin... True Mastery in Analytical Chemistry : Kevin’s foundation in engineering and chemistry allows him to employ high-end instrumentation and soph...
Oct 02, 2023•10 min
This show was recorded 28 September 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! 🙏 The extension of the EU MDR compliance timeline offers a reprieve for medical device manufacturers, but this extended window comes with its own set of challenges and conditions. As the interim deadlines approach, it’s critical for manuf...
Sep 28, 2023•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. 🌟 The plus is the people at RQM+ and our Excellence Spotlight series celebrates them... as well as the significant impact they have on our clients. This week we're delighted to feature Principal Consultant Diane Cox , whose expertise in FDA, ISO, risk, and compliance within ...
Sep 26, 2023•8 min
This show was recorded 21 September 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! 🙏 We all know: ensuring the safety and efficacy of medical devices is critical to protecting patients and minimizing risks to healthcare providers. One of the key challenges in achieving this goal is selecting and managing materials effective...
Sep 22, 2023•54 min
🎥 We're starting off the week right with a NEW MedTech Voices 🚨 Join our Medical Director Sally Sennitt and VP of Intelligence and Innovation Jaishankar Kutty, Ph.D. as they dissect the expert panel review of a groundbreaking neurostimulator designed to treat focal epilepsy in adults. 🧠⚡ Why watch?🤔 1️⃣ Gain Insights into the Complexities of Regulatory Approvals : Understand the expert panel's concerns over data sufficiency and quality, and learn why a well-defined intended use is crucial. 2...
Sep 11, 2023•9 min
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. 🌟 Today, we’re delighted to present another episode of our Excellence Spotlight series, featuring RQM+ Senior Principal Engineer, Pooja Roychoudhury ! 🛠 With over 12 years (!) at RQM+, Pooja is a tour de force in design quality engineering, risk management, usability, 𝘢𝘯𝘥 𝘴𝘰 𝘮𝘶𝘤𝘩 𝘮𝘰𝘳𝘦, as you'll hear in the clip. Her multi-disciplinary educational background, includ...
Sep 06, 2023•8 min
This show was recorded 31 August 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 listening! Certification of Class D devices present additional challenges for manufacturer's due to the additional requirements for these high-risk devices. The challenges are further complicated because the infrastructure required in the IVDR is not fully in pla...
Sep 01, 2023•48 min
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. 🔦 Today, we're back with a BONUS Excellence Spotlight video featuring two case studies from Vice President of Technical, Jonathan Gimbel . Here's a link to Jon's original feature if you haven't seen it. While these case studies will obviously demonstrate Jon's wealth of experience in action (even though he's shy about it!), we also hope they demonstrate the true depth of expertis...
Aug 22, 2023•6 min
🎬 In our latest MedTech Voices clip, RQM+ VP of Intelligence and Innovation Jaishankar Kutty, Ph.D. and Medical Director Sally Sennitt delve into the EU MDR expert panel feedback about a groundbreaking minimally invasive tricuspid valve. Why watch? 🤔 1️⃣ Gain a comprehensive understanding of the intricate balance between benefit and risk as the clip explores the imperative of a Randomized Controlled Trial (RCT) for precise evaluation against guideline-driven medical therapy. The significance o...
Aug 15, 2023•10 min
When we say we have thought leaders at RQM+, we mean it . 👑 Small in duration but big in substance, this four-minute MedTech Voices clip features Senior VP of Intelligence and Innovation Amie Smirthwaite, PhD, FRAPS sharing her ISO 18969 journey. We don't want to say too much because we'll spoil the clip! What we will say is that Amie's initiative is leading to the development of the first ISO standard for clinical evaluation of medical devices . Work is ongoing; while the standard will be harm...
Aug 08, 2023•4 min
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. 🌟 Today as part of our Excellence Spotlight video series we're celebrating RQM+ Principal Regulatory Scientist, Bethany Knorr Chung, PhD, RAC ! 🔢 Bethany is a driving force behind our clinical and post-market operations group. With an exceptional background in math, biology, and biomedical engineering, she's truly a maestro of all things quantitative . 👪 Bethany's journey is a ...
Aug 03, 2023•9 min
This show was recorded 27 July 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 listening! Listen to a captivating and informative conversation aiming to help you master EU compliance, where BSI's Global Head Clinical Compliance Richard Holborow and RQM+'s Senior Vice President of Intelligence and Innovation Amie Smirthwaite come together and ad...
Jul 28, 2023•1 hr
🎬 In a new eye-opening episode of MedTech Voices , Medical Director Sally Sennitt and VP Jaishankar Kutty, Ph.D. – a true expert on cardiac valves – explore the EU MDR expert panel feedback from a minimally invasive tricuspid valve. 🩺 The submitted data from a single-arm study with a short six-month follow up, was found to be insufficient and lacking in quality and quantity... and not supporting a benefit-risk profile. You'll learn considerably more from watching (or listening to) the 10-minut...
Jul 26, 2023•10 min
This show was recorded 29 June 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 listening! This panel discussion was all about the FDA's latest pre-submission guidance, with an emphasis on best practices for Predetermined Change Control Plans (PCCP). As always, we took questions from the audience and answered as many as we could! Key points of ...
Jul 25, 2023•1 hr 5 min
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. Thanks for all the warm messages and feedback in response to our first Excellence Spotlight two weeks ago with Eila Pattee, MS, MLS(ASCP), RAC . Now it's time for round two! 🌟 In this latest episode, we're delighted to introduce none other than Vice President of Technical, Jonathan Gimbel , Ph.D. A problem solver through and through, this clip goes deep into what's made Jon succe...
Jul 19, 2023•10 min
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. At RQM+, 𝐭𝐡𝐞 𝐩𝐥𝐮𝐬 𝐢𝐬 𝐭𝐡𝐞 𝐩𝐞𝐨𝐩𝐥𝐞. We've been saying it, but now it's time to 𝒔𝒉𝒐𝒘 𝒚𝒐𝒖. 🎥 We're thrilled to unveil a new video series shining a spotlight on the outstanding individuals who help keep our clients moving forward! 🔦 Introducing the Excellence Spotlight series, where we celebrate exceptional talents and showcase the remarkable journeys and achi...
Jul 07, 2023•10 min
🗣️ We're excited to release the fifth installment of our MedTech Voices mini series about 𝐄𝐔 𝐌𝐃𝐑 𝐄𝐱𝐩𝐞𝐫𝐭 𝐏𝐚𝐧𝐞𝐥 𝐅𝐞𝐞𝐝𝐛𝐚𝐜𝐤. If you've been following along, this series is all about sharing perspectives on the feedback (CECP per EU MDR, Article 54) from clinical reviews completed over the last year. 𝘐𝘴 𝘵𝘩𝘦 𝘳𝘦𝘱𝘰𝘳𝘵 𝘥𝘪𝘴𝘤𝘶𝘴𝘴𝘦𝘥 𝘪𝘯 𝘵𝘩𝘪𝘴 𝘤𝘭𝘪𝘱 𝘴𝘦𝘯𝘥𝘪𝘯𝘨 𝘢 𝘣𝘢𝘥 𝘮𝘦𝘴𝘴𝘢𝘨𝘦 𝘵𝘰 𝘮𝘢𝘯𝘶𝘧𝘢𝘤𝘵𝘶𝘳𝘦𝘳𝘴? 🤔 👨🏫 Jaishankar Kutty, Ph.D. , VP o...
Jun 28, 2023•10 min
