👋 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
RQM+
Business Consulting and Services
Monroeville, PA 24,241 followers
RQM+ is a global MedTech service provider focused on accelerating compliance and market success.
About us
RQM+ is a global MedTech service provider accelerating compliance and market success. Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for Med Device and IVD companies, from concept to commercialization to post-market. Our portfolio of services enables the delivery of end-to-end solutions across the complete med device product lifecycle, with our: + Regulatory and Quality Consulting + Lab Services (Jordi Labs) + Clinical Trials + Reimbursement + Technology Solutions
- Website
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https://www.rqmplus.com/
External link for RQM+
- Industry
- Business Consulting and Services
- Company size
- 501-1,000 employees
- Headquarters
- Monroeville, PA
- Type
- Privately Held
- Specialties
- Regulatory for Medical Device, Quality Systems for Medical Device, Design Assurance for Medical Device, Product Quality for Medical Device, Post-Market Surveillance for Medical Device, EU MDR, Clinical Evaluation Reports, Remediation, Complaint Remediation, Manufacturing Site Transfer, 510(k), PMA, De Novo, Human Factors, Design Verification and Validation, Design History File Remediation, Design Quality Assurance, and In Vitro Diagnostics
Locations
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Primary
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2790 Mosside Blvd.
Suite 800
Monroeville, PA 15146, US
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Grosspeteranlage 29
Grosspeter Tower
Basel, 4052, CH
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1 Ashley Road
3rd Floor
Altrincham, Cheshire WA14 2DT, GB
Employees at RQM+
Updates
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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
My ramblings about TC210 in Tokyo. Thanks to RQM+ as we work on #evolvingmedtech.
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📢 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
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Trade wars and tariffs are forcing MedTech manufacturers to adapt. Supply chains are strained, costs are surging, and regulatory challenges are escalating. One [in]action that’s 𝘯𝘰𝘵 an option: complacency. 𝗜𝗻 𝗮 𝗯𝗿𝗮𝗻𝗱-𝗻𝗲𝘄 𝗟𝗶𝗻𝗸𝗲𝗱𝗜𝗻 𝗔𝗿𝘁𝗶𝗰𝗹𝗲, Jaishankar Kutty, Ph.D., VP of Global Regulatory Affairs, lays out strategic solutions to: ➡️ Strengthen supply chains ➡️ Manage rising costs ➡️ Navigate regulatory hurdles ➡️ Maintain market access There 𝘪𝘴 an opportunity to emerge stronger and more competitive... 𝗯𝘂𝘁 𝗼𝗻𝗹𝘆 𝗳𝗼𝗿 𝘁𝗵𝗼𝘀𝗲 𝘄𝗶𝗹𝗹𝗶𝗻𝗴 𝘁𝗼 𝗮𝗰𝘁! Read Jai’s full piece below for actionable strategies. 👇 #MedTech #SupplyChain #GlobalTrade #RegulatoryCompliance
$$$ Medtech vs. Tariffs: The Fight of the Decade $$$ Tariffs aren’t just an annoying line item on your balance sheet, they’re supply chain wrecking balls, cost inflators, and regulatory nightmares all rolled into one. But let’s be clear: we at RQM+ are not here to wring our hands; we’re here to help medtech forge a way forward. 🛑 Complacency = Extinction. Smart companies are already: - Reinventing supply chains before tariffs do it for them - Engineering cost-cutting strategies that don’t kill quality - Outsmarting regulatory hurdles instead of getting buried in them - Finding new markets while competitors are stuck in tariff quicksand - Lobbying, litigating, and refusing to roll over Medtech’s next champions aren’t just surviving this tariff era; they’re dominating it. The rest? Just collateral damage. Which side are you on? Read my latest article on how to turn tariffs into a competitive weapon.
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🚨 𝗬𝗼𝘂𝗿 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 𝗗𝗲𝘀𝗶𝗴𝗻 𝗖𝗼𝘂𝗹𝗱 𝗕𝗲 𝗖𝗼𝘀𝘁𝗶𝗻𝗴 𝗬𝗼𝘂 𝗠𝗮𝗿𝗸𝗲𝘁 𝗔𝗰𝗰𝗲𝘀𝘀! 🚨 Designing a trial for 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 is just one piece of the puzzle. If your study doesn’t 𝗮𝗹𝘀𝗼 meet payer requirements, reimbursement delays could stall your MedTech innovation’s success. 💡 Did you know? ✔ A 𝘀𝘂𝗽𝗲𝗿𝗶𝗼𝗿𝗶𝘁𝘆 𝘁𝗿𝗶𝗮𝗹 may be necessary when competing against a lower-cost alternative ✔ 𝗡𝗼𝗻-𝗶𝗻𝗳𝗲𝗿𝗶𝗼𝗿𝗶𝘁𝘆 𝘁𝗿𝗶𝗮𝗹𝘀 can be the key to expanding indications and broadening reimbursement ✔ Without payer-aligned endpoints, your trial could fail to prove economic value—𝗲𝘃𝗲𝗻 𝘄𝗶𝘁𝗵 𝗙𝗗𝗔 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 At RQM+, we specialize in study designs that optimize reimbursement AND regulatory success. In our latest white paper, "𝗧𝗿𝗶𝗮𝗹𝘀 𝗧𝗵𝗮𝘁 𝗣𝗮𝘆," Jaishankar Kutty, Ph.D., Vice President, Global Regulatory Affairs and Margot Borgel, Ph.D., Director, IVD Global Regulatory Affairs, explore 𝗿𝗲𝗮𝗹-𝘄𝗼𝗿𝗹𝗱 𝗰𝗮𝘀𝗲 𝘀𝘁𝘂𝗱𝗶𝗲𝘀 where trial design directly impacted market access—and how to get it right. 📩 Download now and ensure your trial is built for success: https://lnkd.in/eQt3WkpA #MedTech #ClinicalTrials #MarketAccess #Reimbursement #HealthEconomics #MedicalDevices #RQMplus
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🗣️ 𝗟𝗘𝗧'𝗦 𝗧𝗔𝗟𝗞 𝗔𝗕𝗢𝗨𝗧 𝗪𝗢𝗠𝗘𝗡'𝗦 𝗛𝗘𝗔𝗟𝗧𝗛: 𝗧𝗛𝗬𝗥𝗢𝗜𝗗 𝗗𝗬𝗦𝗙𝗨𝗡𝗖𝗧𝗜𝗢𝗡 🦋 The second post in our 𝗟𝗲𝘁'𝘀 𝗧𝗮𝗹𝗸 𝗔𝗯𝗼𝘂𝘁 𝗪𝗼𝗺𝗲𝗻'𝘀 𝗛𝗲𝗮𝗹𝘁𝗵 blog series this month is from Vice President of Marketing and Communications, Victoria Chester Rose. She shares her personal journey with hypothyroidism. "𝘞𝘪𝘵𝘩 𝘢 𝘧𝘢𝘮𝘪𝘭𝘺 𝘩𝘪𝘴𝘵𝘰𝘳𝘺 𝘰𝘧 𝘵𝘩𝘺𝘳𝘰𝘪𝘥 𝘥𝘪𝘴𝘦𝘢𝘴𝘦, 𝘐 𝘬𝘯𝘦𝘸 𝘐 𝘯𝘦𝘦𝘥𝘦𝘥 𝘵𝘰 𝘩𝘢𝘷𝘦 𝘮𝘺 𝘵𝘩𝘺𝘳𝘰𝘪𝘥 𝘵𝘦𝘴𝘵𝘦𝘥. 𝘌𝘢𝘤𝘩 𝘵𝘪𝘮𝘦, 𝘮𝘺 𝘛𝘚𝘏 (𝘵𝘩𝘺𝘳𝘰𝘪𝘥-𝘴𝘵𝘪𝘮𝘶𝘭𝘢𝘵𝘪𝘯𝘨 𝘩𝘰𝘳𝘮𝘰𝘯𝘦) 𝘭𝘦𝘷𝘦𝘭𝘴 𝘸𝘦𝘳𝘦 𝘢𝘵 𝘵𝘩𝘦 𝘩𝘪𝘨𝘩 𝘦𝘯𝘥 𝘰𝘧 𝘵𝘩𝘦 “𝘯𝘰𝘳𝘮𝘢𝘭” 𝘳𝘢𝘯𝘨𝘦, 𝘣𝘶𝘵 𝘴𝘵𝘪𝘭𝘭 𝘸𝘪𝘵𝘩𝘪𝘯 𝘸𝘩𝘢𝘵 𝘸𝘢𝘴 𝘤𝘰𝘯𝘴𝘪𝘥𝘦𝘳𝘦𝘥 𝘢𝘤𝘤𝘦𝘱𝘵𝘢𝘣𝘭𝘦. 𝘛𝘩𝘪𝘴 𝘸𝘦𝘯𝘵 𝘰𝘯 𝘧𝘰𝘳 𝘵𝘸𝘰 𝘺𝘦𝘢𝘳𝘴—𝘵𝘸𝘰 𝘺𝘦𝘢𝘳𝘴 𝘰𝘧 𝘧𝘦𝘦𝘭𝘪𝘯𝘨 𝘶𝘯𝘭𝘪𝘬𝘦 𝘮𝘺𝘴𝘦𝘭𝘧, 𝘵𝘸𝘰 𝘺𝘦𝘢𝘳𝘴 𝘰𝘧 𝘢𝘥𝘷𝘰𝘤𝘢𝘵𝘪𝘯𝘨 𝘧𝘰𝘳 𝘮𝘺 𝘩𝘦𝘢𝘭𝘵𝘩 𝘸𝘩𝘪𝘭𝘦 𝘣𝘦𝘪𝘯𝘨 𝘵𝘰𝘭𝘥 𝘵𝘩𝘢𝘵 𝘐 𝘸𝘢𝘴 𝘴𝘵𝘪𝘭𝘭 𝘸𝘪𝘵𝘩𝘪𝘯 𝘯𝘰𝘳𝘮𝘢𝘭 𝘭𝘪𝘮𝘪𝘵𝘴. 𝘐𝘵 𝘸𝘢𝘴𝘯’𝘵 𝘶𝘯𝘵𝘪𝘭 𝘮𝘺 𝘛𝘚𝘏 𝘴𝘱𝘪𝘬𝘦𝘥 𝘸𝘦𝘭𝘭 𝘪𝘯𝘵𝘰 𝘵𝘩𝘦 𝘩𝘪𝘨𝘩 𝘳𝘢𝘯𝘨𝘦 𝘵𝘩𝘢𝘵 𝘮𝘺 𝘥𝘰𝘤𝘵𝘰𝘳 𝘧𝘪𝘯𝘢𝘭𝘭𝘺 𝘱𝘳𝘦𝘴𝘤𝘳𝘪𝘣𝘦𝘥 𝘮𝘦𝘥𝘪𝘤𝘢𝘵𝘪𝘰𝘯. 𝘽𝙪𝙩 𝙬𝙝𝙮 𝙙𝙞𝙙 𝙞𝙩 𝙝𝙖𝙫𝙚 𝙩𝙤 𝙜𝙚𝙩 𝙩𝙤 𝙩𝙝𝙖𝙩 𝙥𝙤𝙞𝙣𝙩? 𝙒𝙝𝙮 𝙙𝙞𝙙 𝙄 𝙝𝙖𝙫𝙚 𝙩𝙤 𝙬𝙖𝙞𝙩 𝙪𝙣𝙩𝙞𝙡 𝙢𝙮 𝙣𝙪𝙢𝙗𝙚𝙧𝙨 𝙬𝙚𝙧𝙚 “𝙗𝙖𝙙 𝙚𝙣𝙤𝙪𝙜𝙝” 𝙛𝙤𝙧 𝙩𝙧𝙚𝙖𝙩𝙢𝙚𝙣𝙩, 𝙙𝙚𝙨𝙥𝙞𝙩𝙚 𝙚𝙭𝙥𝙚𝙧𝙞𝙚𝙣𝙘𝙞𝙣𝙜 𝙖𝙡𝙡 𝙩𝙝𝙚 𝙝𝙖𝙡𝙡𝙢𝙖𝙧𝙠 𝙨𝙮𝙢𝙥𝙩𝙤𝙢𝙨 𝙤𝙛 𝙝𝙮𝙥𝙤𝙩𝙝𝙮𝙧𝙤𝙞𝙙𝙞𝙨𝙢?" 💪 Victoria's journey demonstrates the importance of 𝗯𝗲𝗶𝗻𝗴 𝘆𝗼𝘂𝗿 𝗼𝘄𝗻 𝗮𝗱𝘃𝗼𝗰𝗮𝘁𝗲. 𝗥𝗲𝗮𝗱 𝗵𝗲𝗿 𝘀𝘁𝗼𝗿𝘆 𝗵𝗲𝗿𝗲: https://lnkd.in/eqX9qM7J Look for another employee story as part of this series and our overall 𝗪𝗲 𝗠𝗮𝗸𝗲 𝗪𝗼𝗺𝗲𝗻'𝘀 𝗛𝗲𝗮𝗹𝘁𝗵 𝙃𝙖𝙥𝙥𝙚𝙣 campaign next week! #WomensHealth #MedTech #ThyroidDysfunction #PatientStories
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Incredible work by Marissa Fayer and HERhealthEQ, bringing essential maternal health technology to communities in Nigeria. 👏 We're honored to have Marissa join us next week for our 𝗕𝘂𝗶𝗹𝘁 𝗳𝗼𝗿 𝗛𝗲𝗿 panel discussion, where she's one of four leaders sharing strategies on advancing women's health in MedTech. Join us live on Thursday, March 20th and bring your questions! 🔗 Registration link in comments. #MedTech #WomensHealth #HealthEquity #Innovation
Health Equity for Women; Medical Device CEO of DeepLook Medical; Nonprofit CEO of HERhealthEQ; Co-Chair US AI for Good; Investment Committee at Goddess Gaia Ventures; EIR at Graybella Capital; TEDx Speaker.
Women around the world deserve access to quality healthcare. Last week HERhealthEQ began the first phase of a maternal health project with the SDGs Lagos commission in Nigeria 🇳🇬!We had the official donation ceremony at their office in Lagos with Special Advisor Oreoluwa Finnih, the Permanent Secretary, the Minstry of Health, and other advisors and team members. I was honored to be able to travel to Lagos Nigeria to be there in person, delivering the equipment. Enhancing maternal health, leading to better child health, is a focus for the Lagos government and this project can serve as an example to other regions on how to partner for the goals. HERhealthEQ donated 10 Butterfly Network, Inc. portable ultrasound probes that will be dispersed to both public and private hospitals around Lagos to strengthen their healthcare capacity. And we plan to work with the team to deploy many more, as the need is large! #PartnershipForTheGoals #HealthTechnology #AccelerateAction #SDG3 #SDG17 #HealthForAll #Healthtech #nonprofit #HERhealthEQ
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📰 Our latest edition of the 𝗥𝗤𝗠+ 𝗪𝗲𝗲𝗸𝗹𝘆 𝗪𝗮𝘁𝗰𝗵 is ready. Here's the latest in #MedTech 👇 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗮𝗻𝗱 𝗚𝗹𝗼𝗯𝗮𝗹 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 — EU releases landmark European Health Data Space (EHDS) regulation. — UK MHRA announces upcoming device registration fee changes. — IMDRF updates adverse event reporting terminologies. 𝗔 𝗣𝗹𝗲𝘁𝗵𝗼𝗿𝗮 𝗼𝗳 𝗨𝗽𝗱𝗮𝘁𝗲𝘀 𝗳𝗿𝗼𝗺 𝗥𝗤𝗠+ From our RQM+ Live! panel and participation in LSI's event next week to a ton of new initiatives and content from us last week (we're celebrating Women's Health this month if you hadn't noticed), please see the full newsletter for all the details! #MedicalDevices #ClinicalTrials #RegulatoryAffairs #WomensHealth
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Women's health innovation. We love those three words together, don't you? Next week, we’ve assembled leaders who aren’t just talking about change... 𝗧𝗵𝗲𝘆'𝗿𝗲 𝗱𝗿𝗶𝘃𝗶𝗻𝗴 𝗶𝘁. Join our expert panel on Thursday, March 20th for real-world strategies to accelerate women's health in MedTech: Marissa Fayer | CEO, HERhealthEQ & DeepLook Medical Megan Callanan | US & Global Regulatory Lead, Natural Cycles° Stephanie Kladakis | EVP, AgNovos Bioscience Alexia Haralambous | Senior Principal, RQM+ Moderated by Jaishankar Kutty, Ph.D., VP Global Regulatory Affairs at RQM+. 📅 March 20 | 11am ET / 4pm CET | Live + Q&A More info below and in the comments! 🔗 #MedTech #WomensHealth #ClinicalTrials #RegulatoryAffairs
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I’m heading to Baltimore for the RAPS Regulatory Global Regulatory Strategy Conference! Join me as I nerd out on "Structured Methods for a Robust Benefit Risk Assessment Throughout the Device Lifecycle " on Tuesday, March 11, 2025 at 2:25 PM. And join Alexia Haralambous and me as we super-nerd out about "From Development to Market: Validation and Updates for CDS Software " on Wednesday, March 12, 2025 at 1:40 PM. https://lnkd.in/eUk_HYZh