RQM+

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... 𝗧𝗼𝗺𝗼𝗿𝗿𝗼𝘄'𝘀 𝗽𝗮𝗻𝗲𝗹 𝗰𝗼𝘃𝗲𝗿𝘀 𝘁𝗵𝗲𝗺 𝗮𝗹𝗹. << 𝘚𝘪𝘨𝘯 𝘶𝘱 𝘢𝘵 𝘵𝘩𝘦 𝘭𝘪𝘯𝘬 𝘪𝘯 𝘵𝘩𝘦 𝘤𝘰𝘮𝘮𝘦𝘯𝘵𝘴. >> 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 𝗥𝗲𝘀𝗲𝗿𝘃𝗲 𝘆𝗼𝘂𝗿 𝘀𝗽𝗼𝘁 𝗻𝗼𝘄 — 𝗹𝗶𝗻𝗸 𝗶𝗻 𝗰𝗼𝗺𝗺𝗲𝗻𝘁𝘀. 👇

In the most unsurprising of updates, our team is 𝗹𝗼𝘃𝗶𝗻𝗴 #LSIUSA25 in Dana Point, CA this week. ☀️ Here are some shots of our VP of MedTech Innovations, Allison Komiyama, PhD, RAC., yesterday. Left – 𝗛𝗲𝗿 𝟱 𝗺𝗶𝗻. '𝗦𝗲𝘀𝘀𝗶𝗼𝗻 𝗟𝗲𝗮𝗱𝗲𝗿' 𝘁𝗶𝗺𝗲 𝘀𝗹𝗼𝘁 𝗲𝘅𝗽𝗹𝗮𝗶𝗻𝗶𝗻𝗴 𝗵𝗼𝘄 𝗥𝗤𝗠+ 𝗵𝗲𝗹𝗽𝘀 #MedTech 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿𝘀. 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, "𝘈𝘥𝘥𝘪𝘯𝘨 𝘦𝘹𝘱𝘦𝘳𝘵𝘪𝘴𝘦 𝘧𝘳𝘰𝘮 𝘤𝘰𝘯𝘤𝘦𝘱𝘵 𝘵𝘰 𝘱𝘰𝘴𝘵-𝘮𝘢𝘳𝘬𝘦𝘵," for anyone wondering. We Don't Make MedTech. 𝗪𝗲 𝗠𝗮𝗸𝗲 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝙃𝙖𝙥𝙥𝙚𝙣. 🟡🟡🟠🟠🔴🟣 Right – Participating in the panel 𝗡𝗲𝘄 𝗔𝗽𝗽𝗿𝗼𝗮𝗰𝗵𝗲𝘀 𝗳𝗼𝗿 (𝗙𝗶𝗻𝗮𝗹𝗹𝘆) 𝗙𝘂𝗻𝗱𝗶𝗻𝗴 𝗮𝗻𝗱 𝗦𝗼𝗹𝘃𝗶𝗻𝗴 𝗨𝗻𝗺𝗲𝘁 𝗡𝗲𝗲𝗱𝘀 𝗶𝗻 𝗪𝗼𝗺𝗲𝗻'𝘀 𝗛𝗲𝗮𝗹𝘁𝗵; 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 𝙩𝙝𝙞𝙨 𝙏𝙝𝙪𝙧𝙨𝙙𝙖𝙮, 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 𝗥𝗤𝗠+ 𝗪𝗲𝗲𝗸𝗹𝘆 𝗪𝗮𝘁𝗰𝗵 is here! See the latest in #MedTech 📰 𝗪𝗼𝗺𝗲𝗻'𝘀 𝗛𝗲𝗮𝗹𝘁𝗵: – Join our live panel 𝘵𝘩𝘪𝘴 𝘛𝘩𝘶𝘳𝘴𝘥𝘢𝘺 to discuss funding, clinical trials, regulatory insights, and innovation in women's health. 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 𝗮𝗻𝗱 𝗥𝗲𝗶𝗺𝗯𝘂𝗿𝘀𝗲𝗺𝗲𝗻𝘁: – Learn how strategic clinical trial design impacts reimbursement and market access in our new white paper by Jaishankar Kutty, Ph.D. 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀: – 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 𝗮𝗻𝗱 𝗚𝗹𝗼𝗯𝗮𝗹 𝗡𝗲𝘄𝘀: – 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 𝗥𝗤𝗠+ 𝗪𝗲𝗲𝗸𝗹𝘆 𝗪𝗮𝘁𝗰𝗵 below. 👇 At RQM+, we don’t make MedTech. We make MedTech happen. 🟡🟡🟠🟠🔴🟣 (...in this case, in your LinkedIn inbox 📥) #MedicalDevices #IVDs #ClinicalTrials #Reimbursement #WomensHealth

𝗜𝗻 𝗷𝘂𝘀𝘁 𝟮 𝗱𝗮𝘆𝘀, 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 𝙩𝙝𝙞𝙨 𝙏𝙝𝙪𝙧𝙨𝙙𝙖𝙮, 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 18ᵗʰ 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 𝗜𝗦𝗢 𝗧𝗖 𝟮𝟭𝟬 𝘄𝗼𝗿𝗸𝗶𝗻𝗴 𝗴𝗿𝗼𝘂𝗽𝘀, 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

📢 We’re hiring. At RQM+, we don’t 𝘮𝘢𝘬𝘦 MedTech. 𝗪𝗲 𝗠𝗮𝗸𝗲 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝙃𝙖𝙥𝙥𝙚𝙣. 🟡🟡🟠🟠🔴🟣 We have several open roles, but today we’re highlighting two key opportunities in clinical trials: 🔹 𝗩𝗶𝗰𝗲 𝗣𝗿𝗲𝘀𝗶𝗱𝗲𝗻𝘁, 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 – 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 Lead strategic sales growth, build long-term client partnerships, and drive high-impact commercialization strategies in the clinical trials space. 🔹 𝗗𝗶𝗿𝗲𝗰𝘁𝗼𝗿, 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 – 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 Expand business opportunities, strengthen client relationships, and generate cross-selling growth in clinical trials and MedTech services. RQM+ helps #MedTech innovators navigate complexity, accelerate approvals, and bring life-changing products to patients: 𝗳𝗮𝘀𝘁𝗲𝗿, 𝘀𝗮𝗳𝗲𝗿, 𝗯𝗲𝘁𝘁𝗲𝗿. 🔗 𝗙𝗶𝗻𝗱 𝗱𝗲𝘁𝗮𝗶𝗹𝘀 𝗼𝗻 𝘁𝗵𝗲 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹 𝗿𝗼𝗹𝗲𝘀 𝗮𝗻𝗱 𝗺𝗼𝗿𝗲 𝗮𝘁 𝘁𝗵𝗲 𝗰𝗮𝗿𝗲𝗲𝗿𝘀 𝗽𝗮𝗴𝗲 𝗹𝗶𝗻𝗸 𝗶𝗻 𝘁𝗵𝗲 𝗰𝗼𝗺𝗺𝗲𝗻𝘁𝘀. #ClinicalTrials #BusinessDevelopment #Hiring #Healthcare