Making MedTech Happen with RQM+

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 stando...

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 root...

🎥  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 pr...

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 Che...

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...

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 delight...

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 provi...

🎥 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 expe...

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...

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. Th...

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...

🎬 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 C...

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 o...

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,...

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 Holbor...

🎬 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 suppo...

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...

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,...

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 serie...

🗣️ 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? 🤔 👨‍🏫  Jaishanka...

📢 We're thrilled to unveil our latest MedTech Voices video! This clip is the fourth installment in our 𝐄𝐔 𝐌𝐃𝐑 𝐄𝐱𝐩𝐞𝐫𝐭 𝐏𝐚𝐧𝐞𝐥 𝐅𝐞𝐞𝐝𝐛𝐚𝐜𝐤 mini series where our experts offer their perspectives on the feedback (CECP per EU MDR, Article 54) from clinical reviews completed over the last year. Jaishankar Kutty, Ph. D. , VP of Intelligence and Innovation, is joined by Medical Director  Sally Sennitt  an...

This show was recorded 25 May 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 is all about navigating off-label use and implementing strategies to improve medical device safety. As we all know, ensuring the safe...

This show was recorded 27 April 2023 and can be viewed on our website ⁠ here ⁠ . The website recording has clickable chapters allowing you to instantly jump to different questions/topics. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠ Knowledge Center ⁠⁠ . What type of evidence is considered sufficient to comply with the MDR? Whil...

Today's new installment of MedTech Voices revisits a series from last year on EU MDR Expert Panel Feedback , where  Jaishankar Kutty, Ph. D.  and  Andreas Tarnaris M.D.  offer their perspectives on the feedback (CECP per EU MDR, Article 54) from clinical reviews completed over the last year. 👂 Why should you listen? 📑 Hear what is being submitted to the notified bodies by manufactures 📋 Hea...

Our experts are back for the final MedTech Voices episode in our 𝗧𝗿𝗮𝘃𝗲𝗿𝘀𝗶𝗻𝗴 𝘁𝗵𝗲 𝗣𝗮𝘁𝗵 𝗳𝗿𝗼𝗺 𝗖𝗘𝗥 𝘁𝗼 𝗣𝗠𝗖𝗙 series. These two 10-minute clips combine clinician and notified body perspectives to share information that will help you avoid errors when approaching your PMCF activities. Featured experts with LinkedIn profile links: 👩‍⚕️  ⁠Sally Sennitt, M.D. – Medical Director⁠ 👨‍⚕️  ⁠Andreas Tarnaris M.D....