RQM+

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

?? Got questions about MedTech innovation, investment, or bringing your device / software to market? We have the expertise and are ready to connect at LSI USA '25 this week. ? Allison Komiyama, PhD, RAC ? Shameek Mohile ? Christine Scheve ?? Stop by our booth, catch Allison’s panel on March 18?? at 12:55, or connect with us throughout the event. #LSIUSA25 #MedTech #MedicalDevices

Our Manager of Intelligence and Strategic Execution, Edward B., was on the ground in Tokyo last week at the latest ?????? ???? ?????? ?????????????? ????????????, ensuring our team stays ahead of risk management, QMS updates, and regulatory shifts that impact the MedTech industry (which includes RQM+ clients, of course). Ed's a sensational storyteller and we strongly encourage you to read his full post (and follow him on LinkedIn), but here are some key takeaways: ?? ISO 13485:2016 review results coming soon ?? Guidance for ISO 13485 is officially in motion ?? ISO 14971 confirmed – no changes for 5 years ?? Machine learning and combination products under the ISO spotlight Ed’s full breakdown reveals what’s changing, what’s staying, and where #MedTech leaders should pay attention next. #ISO13485 #MedicalDevices #RegulatoryAffairs #RiskManagement