? 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: 1️⃣ What were the key triggers for the referral for this evaluation? 2️⃣ Wha ..read more

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. However, one of the key challenges manufacturers face is how to identify and handle off-la ..read more

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 what clinicians on the expert panel are reviewing and commenting on This third episo ..read more

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 President of Intelligence and Innovation For the video version of ..read more

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 Giotto.ai will explore the current and future applications of AI in MedTech, including the use ..read more

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 these expectations and an inappropriate choice of testing labs can result in product delays and repeat t ..read more

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 and enforce regulations at an accelerated pace, the need for speed and flexibility in regulatory func ..read more

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 CER to PMCF plan (regulatory perspective) ⚕️ 4 ..read more

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 perspective) (already recorded and coming next week ..read more

#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 26 May 2026 In order to benefit from this extension, manufacturers cannot make any significant c ..read more