RQM+

???Hold onto your lab coats, folks!??? It's the ???????? ?????????????? of the ??????+ ???????????? ??????????! That's 50 weeks of #MedTech news and insights brought to you by the experts. We've been delivering cutting-edge updates longer than some clinical trials! ???? Dive into this milestone issue and stay ahead in the MedTech world. Don't miss out – your future self will thank you! After all, in the world of MedTech, knowledge is the best prescription! ?? In this issue, we're highlighting job openings, expert analysis, regulatory updates, and innovative breakthroughs in the MedTech industry. Whether you're a seasoned professional or just starting out, our newsletter provides valuable information to help you navigate the ever-evolving landscape. We've got something for everyone in MedTech! ?? Read the 50th edition now and join our community of MedTech enthusiasts! #MedTech #HealthcareInnovation #RQMPlus #WeeklyWatch #MedicalDevices #RegulatoryUpdates #HealthcareNews #Innovation #Milestone

?? ?????? ???????????? ???????? ???? ???????? ???????????????? ?????????? ???????????? ?? Your trial might meet regulatory requirements—but will payers reimburse it? Regulatory compliance keeps your trial breathing but if payers don’t see dollar signs, your MedTech marvel flatlines in the marketplace. A ‘successful’ study that can’t prove economic value? That’s not innovation. It’s a ghost story for investors. ?? ????????: A well-designed trial ensures ????????????, ???????????????? ?????????????????????????? ??????????????????. But many manufacturers focus ???????? on regulatory approval, ?????????????? ?????? ?????????? ???????????????????????? and risking delays, extra costs, or outright rejection. ? ???? ???????? ???????????????? ?????????????????? ?????????? ???????? ?????????? ????????????????????????? ? ???????? ???????? ?????????? ???????????? ???????????????? ???????????????? ??????????, ?????? ???????? ???????????????? ????????????????? ? ?????? ?????? ?????????????????????????? ????????-?????????? ???????????????? ???? ?????????????? ?????????????????????????? ??????????? If you’re unsure, you need to read our latest white paper by Dr. Jaishankar Kutty, Vice President, Global Regulatory Affairs and Dr. Margot Borgel, Director, IVD Global Regulatory Affairs: "???????????? ???????? ??????: ?????????????????? ???????????????? ?????????????? ???? ???????????????? ?????????????????????????? ?????? ???????????? ????????????." Learn from real MedTech case studies where trial design determined reimbursement success—and how to avoid costly missteps. ?? ???????????????? ?????? ?????????? ?????????? ??????: https://lnkd.in/eQt3WkpA #MedTech #ClinicalTrialDesign #ReimbursementStrategy #MarketAccess #HealthEconomics #RQMplus

Estelle Douceron's post on CERs caught some buzz yesterday and since RQM+ has addressed hundreds of notified body (NB) questions for dozens of manufacturers, ?? here's why those manufacturers trust us. ???????????????????? ???????????????? ???????????????????????? Our experience handling countless NB questions gives us unique insights into exactly how reviewers want data presented. ???????????? ???????????????? ?????? ?????????????????????? Leveraging our collective expertise, we deeply understand clinical strategies and regulatory guidance documents, inside and out. ???????????? ???????????????????????? ???????????? ?????????????????? Our templates are proven and have been fine-tuned to allow seamless transfer of information across clinical documents. ???????? ???????? ???????????? We partner closely with clients to fully capture the nuances of their devices, clearly defining their roles within treatment, diagnostics, and patient management. ?????????????? ?????? ?????????????? ???????????????????? ?????????????? ?????? ???????????????? ???? ???????????????? We strategically advise clients to maximize existing data and apply innovative approaches to generate clinical evidence that addresses any gaps.

Is acceptance of MDR CERs without comment from the Notifiy Body a dream? You think it's out of reach? RQM+ did it! ?? Contact us for more information!

Last call for tomorrow's event! ? Funding. Clinical trials. Regulatory hurdles... ????????????????'?? ?????????? ???????????? ???????? ??????. << ???????? ???? ???? ?????? ???????? ???? ?????? ????????????????. >> Hear directly from industry-leading experts driving real progress in women's health MedTech. We'll chat about: ???? Overcoming regulatory and reimbursement barriers ???? Securing funding and investment ???? Enhancing clinical trial diversity and data integrity ? Bringing impactful women's health innovations to market faster Bring your questions, too! Marissa, Megan, Alexia, and Stephanie will be answering them live! Jaishankar will be moderating. ?? Thursday, March 20th | 11am ET / 4pm CET ?????????????? ???????? ???????? ?????? — ???????? ???? ????????????????. ??

In the most unsurprising of updates, our team is ???????????? #LSIUSA25 in Dana Point, CA this week. ?? Here are some shots of our VP of MedTech Innovations, Allison Komiyama, PhD, RAC., yesterday. Left – ?????? ?? ??????. '?????????????? ????????????' ???????? ???????? ???????????????????? ?????? ??????+ ?????????? #MedTech ??????????????????????????. We must say we love seeing our refreshed branding on display for the first time at an event! The small text on the slide reads, "???????????? ?????????????????? ???????? ?????????????? ???? ????????-????????????," for anyone wondering. We Don't Make MedTech. ???? ???????? ?????????????? ????????????. ???????????? Right – Participating in the panel ?????? ???????????????????? ?????? (??????????????) ?????????????? ?????? ?????????????? ?????????? ?????????? ???? ??????????'?? ????????????; joined by Terri Burke of Intuitive Ventures, Matthew V. of Hologic, Inc., Jeyla Sadikova of illumicell AI, and Masha Dumanis of Kx Advisors If you're onsite at LSI and haven't yet, we encourage you to find Allison, as well as RQM+ business development team leaders Shameek Mohile and Christine Scheve! Hope everyone enjoys the rest of the event.

Join me tomorrow, where I'll be speaking with RQM+ and 3 other incredible panelists on their live discussion, Built for Her: Funding, fixing, and fueling the next era of MedTech. The event is ???????? ????????????????, March 20th. Sign up to hear the latest thinking and experiences from me and the incredible other female leaders I'll be speaking with! There will also be live Q&A throughout the event, too. Link here:?? https://lnkd.in/etYhMVc9 #MedTech #WomensHealth #HealthEquity #HERhealthEQ #MedicalDevices #ClinicalTrials #DeepLookMedical

LSI sent me a bunch of photos from today and I legit looked like Madam Mim in all but one of them. So here is the one that I found acceptable for publication. Enough about me, let's talk about the CEOs from the life changing medtech companies I got to introduce at #LSIUSA2025! Thanks to Rick O'Connor from Restera Sleep, Stuart Simpson from THINK Surgical, Peter Vranes from Nutromics, Ryan Shelton from PhotoniCare, Inc., and Rhonda F. Rhyne from Prevencio. I loved learning about how these companies are helping make life better for patients and are bringing breakthrough technologies to healthcare. You inspire me!

The newest ??????+ ???????????? ?????????? is here! See the latest in #MedTech ?? ??????????'?? ????????????: – Join our live panel ???????? ???????????????? to discuss funding, clinical trials, regulatory insights, and innovation in women's health. ???????????????? ???????????? ?????? ??????????????????????????: – Learn how strategic clinical trial design impacts reimbursement and market access in our new white paper by Jaishankar Kutty, Ph.D. ???????????????????? ??????????????: – EU exploring conditional certifications for high-risk medical devices. – UK's NICE updates real-world evidence framework. – Australia's TGA consulting on IVD regulation alignment with the EU. ?????? ?????? ???????????? ????????: – FDA warns testing facility over falsified data. – Dexcom receives FDA warning letter; minimal impact expected. – FDA clears new stroke-treatment catheter and AI-powered diagnostic software. Stay informed each week by subscribing and see this week's full edition of the ??????+ ???????????? ?????????? below. ?? At RQM+, we don’t make MedTech. We make MedTech happen. ???????????? (...in this case, in your LinkedIn inbox ??) #MedicalDevices #IVDs #ClinicalTrials #Reimbursement #WomensHealth

???? ???????? ?? ????????, we're thrilled to feature Marissa Fayer, CEO of HERhealthEQ and DeepLook Medical, as a panelist on our upcoming live discussion, Built for Her: Funding, fixing, and fueling the next era of MedTech. Marissa is an internationally recognized advocate for women's health, TEDx speaker, and award-winning entrepreneur who has spearheaded initiatives improving healthcare access for over 30,000 women globally. The event is ???????? ????????????????, March 20th. Sign up to hear the latest thinking and experiences from Marissa and other female leaders on Thursday! Live Q&A throughout the event, too. Link below. ? ?? https://lnkd.in/etYhMVc9 #MedTech #WomensHealth #HealthEquity #HERhealthEQ #MedicalDevices #ClinicalTrials