RQM+

??????????: this must-watch panel discussion ♀? ?????????? ?????? ?????? – ??????????????, ????????????, ?????? ?????????????? ?????? ???????? ?????? ???? ?????????????? Women’s health is gaining momentum, but challenges remain in ???????????????? ?????????? ??????????????????, ???????????????????? ????????????????, and ??????????????. Watch our ???????? ???? ???????????? ?????????????? to hear industry leaders and regulatory experts share strategies to overcome these barriers and ?????????? ????????-???????????????? ?????????????????????? to market. ???? ?? ?????? ??????????? ? Unlock Market Opportunities ? Gain Regulatory Insights ? Learn from Real-World Success ? Engage in Live Q&A ? Bring Innovations to Market ?? ??????????????????: ? Marissa Fayer – CEO, HERhealthEQ & DeepLook Medical ? Megan Callanan – US & Global Regulatory Lead, Natural Cycles° ? Stephanie Kladakis – EVP, Chief Technology and Regulatory Officer, AgNovos Bioscience ? Alexia Haralambous – Senior Principal, RQM+ ? Jaishankar Kutty, Ph.D. – VP, Global Regulatory Affairs, RQM+ (moderator) ?????????? ?????? ???? ????????????! ?? Link in the comments below ?? #RQMplus #MedTech #WomensHealth #Innovation #ClinicalTrials #RegulatoryAffairs #Healthcare

?? ???????????????? ???????????? ?????????????????????????? ???? ??????+!? ????????????? ? We're hiring for several roles, with a spotlight on two key positions in clinical trials:? ? ?? ???????? ??????????????????, ???????????????? ?????????????????????? – ???????????????? ???????????? Lead strategic sales growth, build long-term client partnerships, and drive impactful commercialization strategies in the clinical trials sector.? ? ?? ????????????????, ???????????????? ?????????????????????? – ???????????????? ???????????? Expand business opportunities, strengthen client relationships, and foster cross-selling growth in clinical trials and MedTech services.? ? ?? ???????????????? ???????? ?????????? ?????????? ?????????? ?????? ?????????? ?????????????????????????? ???? ?????? ?????????????? ????????. ???????? ???? ?????? ????????????????.? ? #RQMplus #ClinicalTrials #BusinessDevelopment #Hiring #Healthcare

???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!