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 implication...
Oct 05, 2023•15 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. Meet RQM+ Director of R&D (and "detective" ) Kevin Rowland in our new Excellence Spotlight ... Two highlights about Kevin... True Mastery in Analytical Chemistry : Kevins foundation in engineering and chemistry allows him to employ high-end instrumentation and s...
Oct 02, 2023•10 min•Transcript available on Metacast 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, its critical for manufacturers to fully understand ...
Sep 28, 2023•59 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. 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•Transcript available on Metacast 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 isselecting and managing materials effectively, while maintaining su...
Sep 22, 2023•54 min•Transcript available on Metacast 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? 1 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 Learn...
Sep 11, 2023•9 min•Transcript available on Metacast Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. Today, were 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, , as you'll hear in the clip. Her multi-disciplinary educational background, including engineering and an MBA, has ...
Sep 06, 2023•8 min•Transcript available on Metacast 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 place. While ...
Sep 01, 2023•48 min•Transcript available on Metacast 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 t...
Aug 22, 2023•6 min•Transcript available on Metacast 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? 1 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 of an ext...
Aug 15, 2023•10 min•Transcript available on Metacast 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 wil...
Aug 08, 2023•4 min•Transcript available on Metacast 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...
Aug 03, 2023•9 min•Transcript available on Metacast 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 youmaster 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 address...
Jul 28, 2023•1 hr•Transcript available on Metacast 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-minute clip...
Jul 26, 2023•10 min•Transcript available on Metacast 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 discussio...
Jul 25, 2023•1 hr 5 min•Transcript available on Metacast 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 ...
Jul 19, 2023•10 min•Transcript available on Metacast Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. At RQM+, . We've been saying it, but now it's time to . 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 achievements of employees. We're starting with Pr...
Jul 07, 2023•10 min•Transcript available on Metacast We're excited to release the fifth installment of our MedTech Voices mini series about . 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. ? Jaishankar Kutty, Ph.D. , VP of Intelligence and Innovation, is joined once more by Medical Director Sally Sennitt . This clip focuses on a transcatheter heart valve likely a balloon-expandable valve and the report wasn't...
Jun 28, 2023•10 min•Transcript available on Metacast We're thrilled to unveil our latest MedTech Voices video! This clip is the fourth installment in our 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 and the two discuss a unique heart valve for adults and children above the age of 12. Questions packed into the 9:58 clip: 1 What were th...
Jun 02, 2023•10 min•Transcript available on Metacast 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 safety and efficacy of medical devices is critical to protecting patients and minimizing risks to healthcare providers...
May 25, 2023•1 hr 1 min•Transcript available on Metacast 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? While we've spoken about this extensively in the past, we'll explore more ways to arrive at the answer and...
Apr 28, 2023•1 hr 2 min•Transcript available on Metacast 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 Hear what has been submitted by the notified bodies for expert panel review Hear a clinician's perspective on wha...
Apr 03, 2023•10 min•Transcript available on Metacast Our experts are back for the final MedTech Voices episode in our 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. Medical Director Jaishankar Kutty, Ph.D. Vice President of Intelligence and Innovation For the video version of this episode, please watch on the RQM+ Link...
Mar 28, 2023•10 min•Transcript available on Metacast Our MedTech Voices 10 minutes or less video/audio series, returns with the first of two new clips in a mini series entitled Traversing the Path from CER to PMCF Clinician Perspective . These two clips will 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. Medical Director Jaishankar Kutty, Ph.D. Vice Pr...
Mar 27, 2023•10 min•Transcript available on Metacast This show was recorded 23 March 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 . Artificial Intelligence (AI) has the potential to revolutionize healthcare and the medical technology industry, with the ability to assist in clinical decision-making, improve patient outcomes, accelerate speed to market and improve efficiency. In this RQM+ Live! show, leaders from RQM+ and ...
Mar 24, 2023•46 min•Transcript available on Metacast This is audio from RQM+ Live! #64 , recorded 16 February 2023. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website. Over the past several years the expectations for testing of medical devices per the ISO 10993 standards has significantly changed and continues to change at a rapid pace. Furthermore, different regulatory bodies have different expectations when evaluating this data. Failure to understand the...
Feb 17, 2023•1 hr 1 min•Transcript available on Metacast This is audio from RQM+ Live! #63 , recorded 26 January 2023. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website. The MedTech industry is one of the most heavily regulated industries in the world. The regulatory landscape is changing rapidly and regulations are increasingly more complex. An efficient and scalable regulatory strategy is now more important than ever. As regulatory bodies worldwide update a...
Jan 27, 2023•1 hr 1 min•Transcript available on Metacast Our PMCF trio is back with another #MedTechVoices clip. Mini series: In this episode, Jaishankar Kutty, Ph.D., Niki Caporali Spaniel, RAC and Torrie DeGennaro explore the path from CER to PMCF plan (regulatory perspective) . We hope you enjoy! The PMCF mini series at a glance: 1. Focused on notified body feedback and key learnings (find the podcast episode or watch on LinkedIn ) 2. Sufficient quality and quantity of clinical evidence (find the podcast episode or watch on LinkedIn ) 3. Path from ...
Jan 23, 2023•10 min•Transcript available on Metacast Our PMCF trio is back with another #MedTechVoices clip! Mini series: In this episode, Jaishankar Kutty, Ph.D., Niki Caporali Spaniel, RAC and Torrie DeGennaro dive into sufficient quality and quantity of clinical evidence . We hope you enjoy! The PMCF mini series at a glance: 1. Focused on notified body feedback and key learnings (find the podcast episode or watch on LinkedIn ) 2. Sufficient quality and quantity of clinical evidence (this one!) 3. Path from CER to PMCF plan (regulatory perspecti...
Jan 18, 2023•10 min•Transcript available on Metacast #MedTechVoices continues in 2023 with Vice President of Intelligence & Innovation, Jaishankar Kutty, who shares additional thoughts on the EU MDR postponement. Here are some key takeaways from today's MDCG proposal to amend the transition timelines for medical devices and IVDs: The new transition timeline for high risk medical devices (i.e. class III and IIb implantables) is now 31 December 2027 For medium and lower risk devices, it's 31 December 2028 For class III custom made devices it's 2...
Jan 06, 2023•5 min•Transcript available on Metacast 
