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. ๐ Why should you listen? ๐ Hear what is being submitted to the notified bodies by manufactures ๐ Hear what has been submitted by the notified bodies for expert panel review ๐ฉบ Hear a clinician's perspe...
Apr 03, 2023โข10 min
Our experts are back for the final MedTech Voices episode in our ๐ง๐ฟ๐ฎ๐๐ฒ๐ฟ๐๐ถ๐ป๐ด ๐๐ต๐ฒ ๐ฃ๐ฎ๐๐ต ๐ณ๐ฟ๐ผ๐บ ๐๐๐ฅ ๐๐ผ ๐ฃ๐ ๐๐ 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: ๐ฉโโ๏ธ โ Sally Sennitt, M.D. โ Medical Directorโ ๐จโโ๏ธ โ Andreas Tarnaris M.D. โ Medical Directorโ ๐จโ๐ผ โ Jaishankar Kutty, Ph.D. โ Vice President of ...
Mar 28, 2023โข10 min
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 โ 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: ๐ฉโโ๏ธ Sally Sennitt, M.D. โ Medical Director ๐จโโ๏ธ Andreas Tarnaris M.D. โ Medical Director ๐จโ๐ผ Jaishan...
Mar 27, 2023โข10 min
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 โ Knowledge Center โ . 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+ ...
Mar 24, 2023โข46 min
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, 2023โข1 hr 1 min
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, 2023โข1 hr 1 min
Our PMCF trio is back with another #MedTechVoices clip. Mini series: โ๏ธ ๐๐ซ๐จ๐๐๐ญ๐ข๐ฏ๐ ๐๐๐๐
๐๐๐ญ๐ ๐ฐ๐ข๐ญ๐ก ๐๐๐จ๐ง๐จ๐ฆ๐ฒ ๐๐ง๐ ๐๐ฑ๐ฉ๐๐๐ข๐๐ง๐๐ฒ 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: ๐ 1. Focused on notified body feedback and key learnings (find the podcast episode or watch on LinkedIn ) ๐ 2. Sufficient qualit...
Jan 23, 2023โข10 min
Our PMCF trio is back with another #MedTechVoices clip! Mini series: โ๏ธ ๐๐ซ๐จ๐๐๐ญ๐ข๐ฏ๐ ๐๐๐๐
๐๐๐ญ๐ ๐ฐ๐ข๐ญ๐ก ๐๐๐จ๐ง๐จ๐ฆ๐ฒ ๐๐ง๐ ๐๐ฑ๐ฉ๐๐๐ข๐๐ง๐๐ฒ 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: ๐ 1. Focused on notified body feedback and key learnings (find the podcast episode or watch on LinkedIn ) ๐ 2. Sufficient quality...
Jan 18, 2023โข10 min
#MedTechVoices ๐ฃ๏ธ 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...
Jan 06, 2023โข5 min
#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, 2022โข10 min
#MedTechVoices ๐ฃ๏ธ 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...
Dec 09, 2022โข5 min
We're back with our second ever episode of #MedTechVoices ๐ฃ๏ธ #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 foc...
Dec 01, 2022โข10 min
We'd like to introduce you to something new: #MedTechVoices ๐ฃ๏ธ #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 yo...
Nov 17, 2022โข9 min
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, โUgh, standards are so boring.โ Yet, how many people actually love standards? How many people always ask, โIs there a standard for this?โ We do at RQM+. The c...
Nov 08, 2022โข1 hr 6 min
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, 2022โข1 hr 1 min
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 weโre ready to share what we learned โ and what surprised us โ from the event. We also answer your questions in the process! This RQM+ Live! show discusses the biggest takeaways and sur...
Sep 26, 2022โข57 min
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, 2022โข1 hr
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, 2022โข1 hr 7 min
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, 2022โข59 min
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 worldโs largest notified bodies, TรV SรD 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:...
Jun 13, 2022โข1 hr 8 min
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, 2022โข50 min
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, 2022โข38 min
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, 2022โข59 min
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, 2022โข48 min
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, 2022โข55 min
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, 2022โข57 min
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, 2022โข48 min
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, 2022โข47 min
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 โ 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 ...
Jan 31, 2022โข53 min
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, 2022โข52 min
