RQM+

From clinical trial diversity to regulatory and investment hurdles, advancing women's health in MedTech isn’t easy. But those who break through ?????? ???????????????? ??????????. We're bringing together ???????? ???? ?????????? ?????????????? ?????? ?????????? ?????????????? ???? ?????? ?????????? for our next live panel discussion. As part of our ???? ???????? ??????????’?? ???????????? ???????????? campaign, this free event will bring together a powerhouse panel (really!) of influential women to share real-world strategies for accelerating progress in women’s health. ?? ?????? ??????????: Marissa Fayer – CEO, HERhealthEQ ?????? DeepLook Medical Megan Callanan – US & Global Regulatory Lead, Natural Cycles° Stephanie Kladakis – EVP, Chief Technology & Regulatory Officer, AgNovos Bioscience Alexia Haralambous – Senior Principal, RQM+ Moderated by Jaishankar Kutty, Ph.D., VP of Global Regulatory Affairs at RQM+ ???????? ????'???? ??????????: ???? The business case for investing in women’s health ?? The toughest regulatory & market hurdles—and how to overcome them ???? How clinical trials are evolving to close the data gap ?? Lessons from industry pioneers bringing innovations to life ?????????? ??????????????: ?? March 20 | 11am ET / 4pm CET | Live panel with Q&A throughout ?? Have tough questions? ?????? ????????. This is a live, unfiltered conversation designed to give you practical, actionable insights. ???????? ???? ???? ?????? ?????????? at the link in the comments! ?? #MedTech #WomensHealth #ClinicalTrials #RegulatoryAffairs

We want to wish all RQM+ and Jordi Labs, an RQM+ Company employees a wonderful Employee Appreciation Day. As CEO John Potthoff shared with our staff this morning, your commitment and contributions are always recognized and appreciated... ...but especially today. ?? ?????? ???????? ???? ???????????? ???????? ?????????? ???? ?????????????????? ?????? ?????????????? ???? ?????? ???????????????? ?????????????????????? ????????. After all, ???? Don't Make MedTech. ???? ???????? ?????????????? ????????????. All of us recognize it's a team effort, through and through! We encourage everyone reading this to reach out to a colleague today and thank them for their work. ?? ???????????? Speaking of team effort, here are pictures of the Jordi Labs team earlier this week. They rolled up their sleeves for a screen-printing party where everyone brought in a variety of items – from T-shirts to bags and even baby onesies – to personalize with our fun?"Nerd Herd" ???logo, created by EVP and General Manager of Lab Services, Kevin Rowland. And what party is complete without ice cream sundaes and cookies? ???? The event blended ????????????????????, ??????????????????????????, ?????? ?????????????????????? to show our unstoppable team just how much their hard work and dedication means to us and our clients. We wish everyone out there a happy Employee Appreciation Day.

Women’s health deserves the spotlight, so we're continuing to shine a light. ?? Hear from our Director of IVD Global Regulatory Affairs, Margot Borgel, Ph.D., on tomorrow's MedTech Leading Voice as we celebrate International Women's Day. ??♀? ???? ???????? ??????'???? ???????? ?????? ????????????????????????.

From clinical trial diversity to regulatory and investment hurdles, advancing women's health in MedTech isn’t easy. But those who break through ?????? ???????????????? ??????????. We're bringing together ???????? ???? ?????????? ?????????????? ?????? ?????????? ?????????????? ???? ?????? ?????????? for our next live panel discussion. As part of our ???? ???????? ??????????’?? ???????????? ???????????? campaign, this free event will bring together a powerhouse panel (really!) of influential women to share real-world strategies for accelerating progress in women’s health. ?? ?????? ??????????: Marissa Fayer – CEO, HERhealthEQ ?????? DeepLook Medical Megan Callanan – US & Global Regulatory Lead, Natural Cycles° Stephanie Kladakis – EVP, Chief Technology & Regulatory Officer, AgNovos Bioscience Alexia Haralambous – Senior Principal, RQM+ Moderated by Jaishankar Kutty, Ph.D., VP of Global Regulatory Affairs at RQM+ ???????? ????'???? ??????????: ???? The business case for investing in women’s health ?? The toughest regulatory & market hurdles—and how to overcome them ???? How clinical trials are evolving to close the data gap ?? Lessons from industry pioneers bringing innovations to life ?????????? ??????????????: ?? March 20 | 11am ET / 4pm CET | Live panel with Q&A throughout ?? Have tough questions? ?????? ????????. This is a live, unfiltered conversation designed to give you practical, actionable insights. ???????? ???? ???? ?????? ?????????? at the link in the comments! ?? #MedTech #WomensHealth #ClinicalTrials #RegulatoryAffairs

We're excited to introduce our new blog series, "??????'?? ???????? ?????????? ??????????'?? ????????????," as part of our "???? ???????? ??????????'?? ???????????? ????????????" campaign this month. ? This series is dedicated to sharing powerful patient impact stories, highlighting the real-life experiences of women navigating various health challenges. Our mission is to raise awareness, foster meaningful dialogue, and shine a light on the key challenges and opportunities in MedTech for women's health.????♀? In our first installment, Meghann Peters, Human Resources Manager at RQM+, shares her personal journey with type 1 diabetes and her appreciation for the MedTech industry and its transformative impact on healthcare. ??? ??????'?? ???????? ?????????? ??????????'?? ????????????: ???????????????? "?????? ?????????? ??????, ???? ?????????? ?????????????? ???????? ?? ?????? ?????????????????? ???????? ???????? 1 ????????????????. ???? ???????? ?????????? ??’?? ???????? ???????????????????????? ?????????????? ?????????????????? ???????????????? ????????, ???????????? ????????????????, ????????’?? ?????????????? ???????? ???? ???? ????????????????. ?????? ??????, ???? ???????????? ?????? ?????????? ???????? ???????? 1 ???????????????? ?????????? ???? ?????? ???????? ?????????? ??????, ?????? ?????? ?????????????? ?????? ???????????? ???? ?? ?????? ?????????? ?????? ?????????????????? ???? ?????? ??????????????..." Read more about Meghann's inspiring story and the advancements in diabetes care that have made a significant difference in her life here ?? https://lnkd.in/e4s-tYiq Stay tuned for more inspiring stories and insights in our ongoing series. Together, we can make women's health happen. ?? ?????????????????? ???? ?????? ???????? to receive the latest updates and insights from our "We Make Women's Health Happen" campaign. Don't miss out on inspiring stories and valuable information on women's health here: https://lnkd.in/e5KxjecA #WomensHistoryMonth #WomensHealth #MedTech #DiabetesAwareness #PatientStories #HealthcareInnovation #WeMakeWomensHealthHappen #RQMplus

In advance of ?????????????????????????? ??????????'?? ??????, RQM+ Director of IVD Global Regulatory Affairs, Margot Borgel, Ph.D., will be a special guest on MedTech Leading Voice ???????? ????????????. Through an interactive presentation, she’ll lead a critical discussion on the challenges and opportunities in women’s health technologies, including: ♀? Gaps in research, approvals, and commercialization ♀? How bias impacts medical device development and clinical trials ♀? Regulatory requirements for gender representation This interactive session is open to women and allies across #MedTech! It’s also part of RQM+’s broader initiative throughout March to spotlight women’s health in MedTech. ???? ???????? ??????'???? ???????? ?????? ????????????????????????. ?? Friday, March 8, 2025 | ?? 11am ET / 8am PT #WomensHealth #InternationalWomensDay #RegulatoryAffairs #MedicalDevices #ClinicalTrials Sean Smith

????????? ???????????? ???? #MedTech: ------------------------------- ?????? ?????? ???????????? ??????????????: New EU guidance, clinical evidence requirements, and data strategies. Webinar featuring Bethany Knorr Chung, PhD, RAC tomorrow. ??????+ ?????????? ???????????????? ????????????????????????: We don’t make MedTech. ???? ???????? ?????????????? ????????????. ???????????? ???????????????????? ????????????: Swissmedic updates FSCA guidance, UK delays sunsetting key EU laws, MedTech Europe calls for clinical strategy clarity. ?????????????? ?????? ???????????? ????????????: Stroke risks in ablation catheters, patient falls due to incorrectly positioned tables, and more. FDA ??????????????????: First hormone-free IUD in 40 years, Medtronic’s new Parkinson’s treatment, Tandem Diabetes Care’s insulin pump for Type 2 diabetes. Read the full breakdown in this week’s edition of the ??????+ ???????????? ??????????.

Remember when we told you ???? ???????? ?????????????? ???????????? last week? ????????'?? ??????????. ? Congrats to SynerFuse on completing the first study of their groundbreaking e-TLIF procedure, combining spinal fusion with direct nerve stimulation to tackle chronic back pain. ?????? ?????????? ???????? ??????????????????. ?? From regulatory strategy to clinical trials, RQM+ helped clear the path to bring this innovation forward. If you're bringing bold #MedTech to market, we’re the partner to ???????? ???? ????????????. ?????? ???????????????? – ????'???? ????????????????. ?? Read more in SynerFuse's post below and we've linked to the full story in Becker's Healthcare in the comments.

Tomorrow, RQM+’s own Bethany Knorr Chung, PhD, RAC takes the stage alongside Amelia Hufford of 3Aware to tackle one of the most pressing topics in #MedTech: ????????-?????????? ???????????????? (??????) ?????? ???????????? ?????????????? ?????????? ?????? ???? ???????????????? & ???????????? ????????'???? ??????????: ?? How orphan devices are defined and the biggest misconceptions ?? The level of clinical evidence needed for pre-market approval ?? How manufacturers can justify orphan status and data sufficiency ?? The role of bias and health equity in data transferability ?? Strategies for sourcing and collecting post-market clinical data Link to sign up for the free event in the comments. ?? #RegulatoryAffairs #OrphanDevices #RealWorldEvidence #ClinicalTrials #EUMDR

We are proud to sponsor the LSI ?????? '???? ???????????????? ?????????????? ???????????? in Dana Point, California from March 17-21! ?? Join us for an incredible event where innovation meets opportunity. ?? ?????????????? ???????? ?????? ???????? ??????????????, Allison Komiyama, PhD, RAC, Shameek Mohile, and Christine Scheve, who will be attending the conference. They are eager to network and share insights with you! ?? Don't forget to visit our booth to learn more about how we can support the full lifecycle of your device. We also have some exciting activities lined up on ??????????????, ?????????? ????: ? ?????????? ???????????????????? ???? ????:???? ????:?Allison will be speaking on the panel "New Approaches for (Finally) Funding and Solving Unmet Needs in Women's Health." ? ?????????????? ???????????? ???? ??:???? ???? in track 5 We look forward to seeing you there and working together to shape the future of #MedTech! ?? #LSIAlumni #Innovation #healthtech #WomensHealth #Networking #RQMPlus #LSIUSA25