#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, Jaishankar Kutty, Ph.D. is joined by Niki Caporali Spaniel, RAC and Torrie DeGennaro. Our current plan ...
Dec 13, 2022•10 min•Transcript available on Metacast #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 asked for one single date as opposed to a staggered one based on classifications. There will be a leg...
Dec 09, 2022•5 min•Transcript available on Metacast 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 second in a series of eight named, "EU MDR expert panel feedback... let it sink in." This clip is focused...
Dec 01, 2022•10 min•Transcript available on Metacast 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 episode is the first in a series of eight named, "EU MDR expert panel feedback... let it sink in." If you're...
Nov 17, 2022•9 min•Transcript available on Metacast 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 actually love standards? How many people always ask, Is there a standard for this? We do at RQM+. The consi...
Nov 08, 2022•1 hr 6 min•Transcript available on Metacast 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 regulatory experts will discuss both FDA and EU deficiencies and additional information requests associated w...
Oct 14, 2022•1 hr 1 min•Transcript available on Metacast 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 were ready to share what we learned and what surprised us from the event. We also answer your questions in the process! This RQM+ Live! show discusses the biggest takeaways and surprise...
Sep 26, 2022•57 min•Transcript available on Metacast 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 that clinical evidence is not clinical performance can still be hard for manufacturers to get their...
Jul 22, 2022•1 hr•Transcript available on Metacast 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 treatment to improve patient outcomes and identify those patients who have an increased risk for serious...
Jul 15, 2022•1 hr 7 min•Transcript available on Metacast 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 medical device companies trying for their first product clearance/approval. Our panelists recently sup...
Jun 30, 2022•59 min•Transcript available on Metacast 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 worlds largest notified bodies, TV SD and BSI, to discuss IVDR implementation challenges and lessons learned so far. A lot has happened since October 2020, when notified bodies issued the first IVDR certificates. In this session we will discuss: No...
Jun 13, 2022•1 hr 8 min•Transcript available on Metacast 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 commonly taken, the result is a product box covered in labels or inconsistent language and placement ac...
May 24, 2022•50 min•Transcript available on Metacast 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 regulatory authorities require compliance to the internationally recognized regulatory requirements of ISO ...
May 24, 2022•38 min•Transcript available on Metacast 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 attendance, which means scheduling a sequel is a no-brainer. The discussion between the audience and our ex...
Apr 26, 2022•59 min•Transcript available on Metacast 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 interpretations continue to evolve, further increasing the challenge. Rollover questions we'll kick the ...
Apr 11, 2022•48 min•Transcript available on Metacast 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 bodies are findings in IVDR submissions) Scoping state of the art from a physician's perspective, ensu...
Mar 29, 2022•55 min•Transcript available on Metacast 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 a 6+ month review time is currently the norm. Errors and deficiencies are commonly found in the int...
Mar 14, 2022•57 min•Transcript available on Metacast 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 learned based upon case studies of successes, failures, and notified body feedback so far. Question...
Mar 01, 2022•48 min•Transcript available on Metacast This is the audio from RQM+ Live! #48, recorded 10 February, 2022. The session description below has been abbreviated in order to list the questions. On 26 August, 2021, we conducted a Live! show on the topic of sustaining EU MDR and IVDR, and we were flooded with audience questions... which we loved! We ran out of time and promised a round two to give everyone a chance to pose their questions to our panel of former notified body leaders and industry experts. Five months have passed and our educ...
Feb 15, 2022•47 min•Transcript available on Metacast This is the audio from RQM+ Live! #47 , recorded 27 January, 2022. The session description below has been abbreviated in order to list the questions. The equivalence requirements of MDR Article 61 Sections 4 and 5 have been interpreted conservatively thus far by notified bodies and industry. It's simple for Class III and implantable devices, the manufacturer cannot leverage data from an equivalent device unless the equivalent device either belongs to that manufacturer or that manufacturer has a ...
Jan 31, 2022•53 min•Transcript available on Metacast This is the audio from RQM+ Live! #46 , recorded 13 January, 2022. As we enter 2022, we'd like to reflect on what's happened over the past year in the world of FDA and medical devices. We'll be sharing our insights to how the Agency did in 2021 and a recap of the most important, cross-cutting regulatory changes. Additionally, we'll provide a forecast of what we can expect in 2022. This discussion will cover the following and more: Impact of COVID on FDA resources and submission ti...
Jan 18, 2022•52 min•Transcript available on Metacast This is the audio from RQM+ Live! #45 , originally recorded 16 December, 2021. Generating evidence of biocompatibility continues to be a significant challenge to regulatory submission success and product-to-market timelines. And global requirements and interpretations continue to evolve, further increasing the challenge. In this show, we will discuss the changes to standards in recent years, whats on the horizon for 2022, and answers to common questions we receive like the following: Is the bioc...
Jan 06, 2022•50 min•Transcript available on Metacast The RQM+ team has collected PMCF data from surveys on thousands of patients and charts on hundreds of devices, and we're excited to share our case studies. In this Live! show we will dive into our PMCF survey successes and discuss the ways that surveys have significantly helped manufacturers maintain label indications by providing a process for collecting data to support all claims, indications, and user populations. The survey approach has saved our clients significant amounts of money (in the ...
Dec 03, 2021•50 min•Transcript available on Metacast This is the audio from RQM+ Live! #43 , originally recorded 11 November, 2021. MDCG 2021-24: Guidance on Classification of Medical Devices was released in October 2021, clarifying spinal implantable medical device classifications. Related MDR language published in 2017 left room for interpretation. In the absence of official guidance over the past 4+ years of transitioning to the MDR, manufacturers made the case for IIb classification, which was reinforced in 2018 when Team NB published a positi...
Nov 11, 2021•54 min•Transcript available on Metacast This is the audio from RQM+ Live! #41 , originally recorded 14 October, 2021. Your post-market surveillance (PMS) system complying to the EU MDR was put into place in May 2021. How is it going? Now months later, there are an abundance of issues and questions! This panel discussion provides a unique opportunity to learn from the experiences of seasoned experts as they share PMCF successes and failures theyve seen across the industry so far. While there have been and will continue to be plen...
Oct 15, 2021•51 min•Transcript available on Metacast This is the audio-only version of RQM+ Live! #40 , originally recorded 30 September, 2021. This has been a very common question from device manufacturers since FDA issued guidance on least burdensome almost 20 years ago. FDA defines least burdensome to be the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time. Some manufacturers have strong opinions about pushing back on FDA with the argument o...
Oct 01, 2021•39 min•Transcript available on Metacast This is the audio-only version of RQM+ Live! #39 , originally recorded 26 August, 2021. The climb to MDR certification is well underway for device manufacturers. It's been quite an undertaking, but with careful planning, budgeting and execution, it has and will lead to continued successful commercialization of medical devices and IVDs in the EU. However, achieving certification is just the beginning. Compared to the MDD and IVDD, it will be quite challenging keeping up with all the new requireme...
Aug 27, 2021•45 min•Transcript available on Metacast This is the audio-only version of RQM+ Live! #38 , originally recorded 22 July, 2021. Market consolidation and acquisitions along with the relocation of design centers and manufacturing facilities to OUS locations are resulting in what appears to be a continuous cycle of site transfers for medical device companies. RQM+ is a strategic partner to these companies, providing all things regulatory and quality associated with the transfers. Our subject matter experts have case studies, lessons learne...
Jul 23, 2021•40 min•Transcript available on Metacast This is the audio-only version of RQM+ Live! #37 , originally recorded June 17, 2021. The U.S. FDA provides multiple pathways to expedite regulatory clearance/approval for much needed innovative devices. As a regulatory consultancy, we've had the opportunity to support manufacturers achieve successful entry to the market using these various pathways. We're very excited about FDA's recently released Safer Technologies Program (STeP) Guidance Document which fills in the gaps for devices that targe...
Jun 18, 2021•39 min•Transcript available on Metacast This is the audio recording from our panel discussion at the MassMEDIC Mid-Year FDA Update event held on April 20, 2021. You can watch the panel discussion on our website here . RQM+ is an Associate Member of MassMEDIC and is sponsoring their FDA series this year (look for another event in December). We're always delighted to collaborate with the team at MassMEDIC. FDA Submissions in 2021: How's it going? With a focus on FDA regulatory submissions, this panel discussion will provide context for ...
Jun 09, 2021•52 min•Transcript available on Metacast 
