Making MedTech Happen with RQM+

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: 👩‍⚕️...

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 outc...

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, differen...

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 s...

Our PMCF trio is back with another #MedTechVoices clip. Mini series: ⚙️ 𝐏𝐫𝐨𝐚𝐜𝐭𝐢𝐯𝐞 𝐏𝐌𝐂𝐅 𝐃𝐚𝐭𝐚 𝐰𝐢𝐭𝐡 𝐄𝐜𝐨𝐧𝐨𝐦𝐲 𝐚𝐧𝐝 𝐄𝐱𝐩𝐞𝐝𝐢𝐞𝐧𝐜𝐲 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 po...

Our PMCF trio is back with another #MedTechVoices clip! Mini series: ⚙️ 𝐏𝐫𝐨𝐚𝐜𝐭𝐢𝐯𝐞 𝐏𝐌𝐂𝐅 𝐃𝐚𝐭𝐚 𝐰𝐢𝐭𝐡 𝐄𝐜𝐨𝐧𝐨𝐦𝐲 𝐚𝐧𝐝 𝐄𝐱𝐩𝐞𝐝𝐢𝐞𝐧𝐜𝐲 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 pod...

#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...

#MedTechVoices continues with the first episode of a brand new mini series: Proactive PMCF Data with Economy and Expediency (#1). This series is about looking at the successes that RQM+ has had over time in collecting data of sufficient quality and quantity for legacy devices across all device classifications... and sharing our learnings and strategies along the way. For the first video/audio, Jai...

#MedTechVoices 🗣️ continues with Vice President of Intelligence & Innovation, Jaishankar Kutty, who shares his thoughts on the EU MDR postponement. Earlier today, in the EPSCO meeting, all EU member states unanimously agreed to the proposal recommendations listed below. Belgium asked for a detailed root cause analyses of why the MDR roll out finds itself where it is today.  Malta has aske...

We're back with our second ever episode of #MedTechVoices 🗣️ #MedTechVoices is our ongoing video/audio series that provides an avenue for our seasoned, industry-leading experts to share their thoughts and advice when inspiration strikes... and in 10 minutes or less. Whenever you see a podcast title beginning with "#MedTechVoices," you can expect a podcast 10 minutes or less. This episode is our se...

We'd like to introduce you to something new: #MedTechVoices 🗣️ #MedTechVoices will be our ongoing video/audio series that provides an avenue for our seasoned, industry-leading experts to share their thoughts and advice when inspiration strikes... and in 10 minutes or less. Whenever you see a podcast title beginning with "#MedTechVoices," you can expect a podcast 10 minutes or less. Our debut episo...

This is audio from RQM+ Live! #62 , recorded 3 November, 2022. 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. Most of us have used standards in some shape or form. There are those that assume they know all about standards, and those who think, “Ugh, standards are so boring.” Yet, how many people actua...

This is audio from RQM+ Live! #61 , recorded 13 October, 2022. 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. Each year RQM+ supports hundreds of FDA 510(k)'s and EU technical documentation files for either medical devices containing software or stand-alone software devices. In this show our regulator...

This is audio from RQM+ Live! #60 , recorded 22 September, 2022. 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. Several RQM+ industry leaders contributed to this year's program at the RAPS Convergence in Phoenix, and we’re ready to share what we learned — and what surprised us — from the event. We als...

This is audio from RQM+ Live! #59 , recorded 21 July, 2022. 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. MDCG 2022-2 was intended to provide guidance on how to demonstrate clinical evidence, however we continue to receive so many questions and requests for support around this topic. The concept...

This is audio from RQM+ Live! #58 , recorded 14 July, 2022. 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. Companion diagnostics (CDx) are critical to patient safety when taking potentially life-saving drugs, e.g. in oncology. CDx can help identify which patients will benefit from a specific drug trea...

This is audio from RQM+ Live! #57 , recorded 30 June, 2022. 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. At RQM+ we're often asked about the FDA appeals process and if it's worth the effort and perceived consequences. The thought of going head-to-head with FDA is intimidating, especially to small me...

This is audio from RQM+ Live! #56 , recorded 9 June, 2022. To join us live for future shows and ask your own questions, please view and register for upcoming sessions in the Knowledge Center at our website. RQM+ is bringing together expertise from the world’s largest notified bodies, TÜV SÜD and BSI, to discuss IVDR implementation challenges and lessons learned so far. A lot has happened since Oct...

This is the audio from RQM+ Live! #55 , recorded 19 May, 2022. Listen and learn why the MDR / IVDR labeling requirements are a great opportunity to start with a blank slate and achieve global market compliance. Medical device and IVD labeling has always been a challenge for manufacturers because updates are often required when new regulations are introduced. With the piecemeal approach that is com...

This is the audio from RQM+ Live! #54 , recorded 5 May, 2022. Listen as our panelists provide insight on the changes in the new requirements and what steps companies should take to update their quality system. FDA requires companies to conform to the current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR 820). However, many other international regulat...

This is the audio from RQM+ Live! #53 , recorded 21 April, 2022. Please note we have not listed the questions asked during the show in this description because there were too many to fit! You can still see a list of them on the video recording page after filling out the form on our website here .   Our Live! discussion topic "PSURs - Ready, Set, Go!" on 24 February had record-breaking attenda...

This is the audio from RQM+ Live! #52 , recorded 7 April, 2022. During our previous show on this topic we were flooded with questions from viewers (which we love!) and couldn't answer them all, so we're back for a sequel. Generating evidence of biocompatibility continues to be a significant challenge to regulatory submission success and product-to-market timelines. And global requirements and inte...

This is the audio from RQM+ Live! #51 , recorded 24 March, 2022.  In this session, our panel of clinicians (including a neurosurgeon and anesthesiologist) will discuss ways that they work with regulatory affairs teams to improve outcomes for submissions, including the following: Scoping intended use/purpose and clinical indications (incorrect scoping is currently the biggest issue notified bo...

This is the audio from RQM+ Live! #50 , recorded 10 March, 2022. A "notified body application" for IVDR CE certification can feel like 510(k) submission to IVD manufacturers who are new to the notified body relationship. Notified bodies are quoting a range of < 1month to 6+ months review time based upon application quality. Per the notified bodies, the majority of applications have problems, so...

This is the audio from RQM+ Live! #49 , recorded 24 February, 2022. The session description below has been abbreviated significantly in order to list the questions covered. You can read the full description here . Whether you've already created PSURs and are looking for ways to optimize and improve, or haven't started yet, you'll want to hear our panel of experts discuss best practices and lessons...