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Anders Horn shared thisIt is RESI Boston next week, and I'll be there both days. Most of the companies I talk to at these things aren't stuck on the science. They're stuck on sequencing: what to submit, when, and what the FDA is going to want to see that they haven't built yet. If that's where you are, find me. #RESIBoston #MedTech #FDA #Accorto Regulatory Solutions #LifeSciences
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Anders Horn reposted thisAnders Horn reposted thisAccorto is heading to ADLM 2026 in Anaheim, July 27 to 30. Anders Horn and Eric Jacobson will both be on site all week. If you're working through early-stage regulatory strategy, cGMP compliance, FDA submissions, or clinical and non-clinical study planning, reach out to set up a time to connect.
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Anders Horn shared thisExcited to be attending BIO International Convention 2026 and RESI San Diego this week. If you're attending BIO or RESI, I'd welcome the opportunity to connect and discuss how regulatory strategy, quality systems, clinical development, and commercialization planning can accelerate growth and reduce risk. See you in San Diego! #BIO2026 #BIOInternational #RESI #Biotech #MedTech #LifeSciences #HealthcareInnovation #RegulatoryAffairs #MedicalDevices #BusinessDevelopment #Networking
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Anders Horn reposted thisAnders Horn reposted thisThe Accorto team is heading to San Diego next week for BIO International Convention and RESI (June 22-25)! Our Director of Business Development, Anders Horn, will be on-site and would love to connect. If your company is working through early-stage regulatory strategy, FDA submissions, cGMP compliance, or clinical and non-clinical studies, this is a great opportunity to have a real conversation about where we can help. 📍 San Diego, CA | June 22-25 To set up time in advance, reach out to Anders directly: andersh@accortoreg.com | 619-315-9188 #BIO2026 #RESI #MedTech #LifeSciences #RegulatoryAffairs #FDASubmissions #MedicalDevice #cGMP
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Anders Horn shared thisExcited to be heading to New Orleans this weekend for #ACC2026! Looking forward to connecting with old colleagues and exploring the latest innovations shaping cardiology, especially the new technologies that are pushing the boundaries of patient care and outcomes! Cardiology has always been one of my favorite specialties, so it’s especially exciting to be part of these conversations and see where the field is headed. If you’re attending, I’d love to connect! #ACC #Cardiology #MedTech #RegulatoryAffairs #ClinicalResearch #Networking #NewOrleans Accorto Regulatory Solutions
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Anders Horn shared thisExcited to be attending the LSI Show representing Accorto Regulatory Solutions! Looking forward to connecting with leaders across the life sciences and medtech ecosystem. If you're an innovator, let's connect and talk about how to navigate the regulatory pathway and get your technology successfully to market. If you're an investor, I’m working with some exciting companies and innovations we’re seeing in the space, so reach out as well! #LSI #MedTech #LifeSciences #HealthcareInnovation #MedTechInvesting
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Anders Horn reposted thisAnders Horn reposted this𝘓𝘦𝘵'𝘴 𝘬𝘦𝘦𝘱 𝘵𝘩𝘦 𝘯𝘦𝘵𝘸𝘰𝘳𝘬𝘪𝘯𝘨 𝘨𝘰𝘪𝘯𝘨.. 🚀 𝐄𝐯𝐞𝐧𝐭𝐬 𝐟𝐨𝐫 𝐭𝐡𝐞 𝐒𝐭𝐚𝐫𝐭𝐮𝐩 & 𝐈𝐧𝐯𝐞𝐬𝐭𝐢𝐧𝐠 𝐄𝐜𝐨𝐬𝐲𝐬𝐭𝐞𝐦 💻 𝘖𝘯𝘭𝘪𝘯𝘦 - 𝐔𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝𝐢𝐧𝐠 𝐭𝐡𝐞 𝐅𝐃𝐀 𝐏𝐫𝐨𝐜𝐞𝐬𝐬 𝐟𝐨𝐫 𝐈𝐧𝐯𝐞𝐬𝐭𝐨𝐫𝐬 𝐚𝐧𝐝 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐨𝐫𝐬 - Mon, 9 Mar https://lnkd.in/dwDEXRCM Martha Chamberlin - Anders Horn 🇪🇸 𝘉𝘢𝘳𝘤𝘦𝘭𝘰𝘯𝘢 - 𝐖𝐨𝐦𝐞𝐧 𝐈𝐧𝐯𝐞𝐬𝐭𝐨𝐫𝐬' 𝐋𝐮𝐧𝐜𝐡 - Wed, 11 Mar https://lnkd.in/dVdN4idj Astghik Zakharyan - Edelweiss Villoria - Ife Desamours 🇪🇸 𝘉𝘢𝘳𝘤𝘦𝘭𝘰𝘯𝘢 - 𝐒𝐭𝐚𝐫𝐭𝐮𝐩/𝐈𝐧𝐯𝐞𝐬𝐭𝐨𝐫 𝐎𝐩𝐞𝐧 𝐂𝐨𝐟𝐟𝐞𝐞 - Thu, 12 Mar https://lnkd.in/d8GKrQjQ Astghik Zakharyan 📸 𝘈 𝘨𝘭𝘪𝘮𝘱𝘴𝘦 𝘧𝘳𝘰𝘮 𝘵𝘩𝘦 𝘍𝘦𝘣𝘳𝘶𝘢𝘳𝘺 𝘦𝘥𝘪𝘵𝘪𝘰𝘯 𝘰𝘧 𝘰𝘶𝘳 𝘞𝘰𝘮𝘦𝘯 𝘐𝘯𝘷𝘦𝘴𝘵𝘰𝘳 𝘓𝘶𝘯𝘤𝘩 — 𝘢 𝘭𝘰𝘷𝘦𝘭𝘺 𝘮𝘪𝘹 𝘰𝘧 𝘸𝘰𝘮𝘦𝘯 𝘤𝘰𝘮𝘪𝘯𝘨 𝘵𝘰𝘨𝘦𝘵𝘩𝘦𝘳 𝘧𝘰𝘳 𝘵𝘩𝘰𝘶𝘨𝘩𝘵𝘧𝘶𝘭 𝘤𝘰𝘯𝘷𝘦𝘳𝘴𝘢𝘵𝘪𝘰𝘯𝘴 𝘢𝘯𝘥 𝘨𝘳𝘦𝘢𝘵 𝘧𝘰𝘰𝘥. --- 📅 𝘌𝘹𝘱𝘭𝘰𝘳𝘦 𝘰𝘶𝘳 𝘌𝘜-𝘸𝘪𝘥𝘦 𝘦𝘷𝘦𝘯𝘵𝘴 https://lnkd.in/dCUiaMpB 💡 SIA is the creator of 𝐓𝐀𝐀𝐂, the Trans-Atlantic Angel Conference: 𝘢 𝘩𝘢𝘯𝘥𝘴-𝘰𝘯, 𝘨𝘭𝘰𝘣𝘢𝘭 𝘱𝘳𝘰𝘨𝘳𝘢𝘮 𝘸𝘩𝘦𝘳𝘦 𝘢𝘯𝘨𝘦𝘭𝘴 𝘭𝘦𝘢𝘳𝘯 𝘣𝘺 𝘥𝘰𝘪𝘯𝘨 — evaluating startups, running due diligence, and investing together. It also doubles as a live pitch competition for founders. 𝘛𝘈𝘈𝘊 9 𝘢𝘱𝘱𝘭𝘪𝘤𝘢𝘵𝘪𝘰𝘯𝘴 𝘢𝘳𝘦 𝘰𝘱𝘦𝘯: https://lnkd.in/dZkSAaAf
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Anders Horn reposted thisAnders Horn reposted thisGreat reconnecting with Anders Horn from Accorto Regulatory Solutions, specializing in FDA regulatory services. I first met him in Silicon Valley, California, and now meeting again at Arab Health Dubai##ArabHealth #Dubai #RegulatoryAffairs #HealthcareInnovation
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Anders Horn shared thisMD&M was a blast! Thank you to everyone who connected and came by the Accorto Regulatory Solutions booth. Now off to #Dubai for WHX Dubai!Anders Horn shared thisMD&M West 2026 is off to a great start! It has been non-stop for our team for the past two days: reconnecting with some of our favorite faces in the industry, making new connections, and working with device developers and manufacturers to find solutions to the regulatory and compliance challenges they face every day. Today is the third and final day we'll be in Anaheim, so if you haven't yet stopped by, make sure to come visit us at booth #516 (downstairs)! #MDM26 #Meddevice #regulatory #compliance #quality Anders Horn Russell Rogers Natasha Trusevich Kristina Haysmer Jason Krull
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Clint Trapp absolutely will do! See you later today
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Anders Horn liked thisAnders Horn liked thisWhat a month it's been ✨ Prototypes in hand. An independent regulatory assessment done. And Paul Clark of Eleven Borders saying yes to joining me as a regulatory adviser, which honestly still makes me smile. In two weeks I'm off to Stanford for the CEO Summit, by invitation. A NICU nurse from Brisbane, packing a suitcase for Palo Alto. I'm still pinching myself. Then straight home to BEDA's Shark Tank and AusBiotech on the Gold Coast. But the moment that stopped me in my tracks this month had nothing to do with work. My niece arrived safely into the world. I've held a lot of newborns in my career. Holding her was entirely different. 💗 It reminded me what my purpose is: every baby deserves the gentlest, safest start. #NeoDuoFlo #NeonatalCare #MedTech #FounderJourney #NursesOnLinkedIn #WomenInMedTech
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Anders Horn liked thisAnders Horn liked thisNext month I'm at the AdvaMed Board of Directors dinner in Boston, representing RQM+, the CRO that focuses on solving complex device problems. I've been thinking about what I owe that room. Most of the conversation at a table like that is about what's next. Where AI goes, where capital goes, which market opens up. Those are good conversations and I want to be in them. But I spend my weeks with the people who have to make "what's next" survive contact with a regulator, a lab and a clinical protocol. Their question is a different one. It usually sounds like: we know what to build, so why is it taking this long to get it to a patient? That gap is what I want to carry into the room. Not as a complaint. As the real constraint on how fast any of this moves. This year's theme is Medtech Moves Us. I'd add a few words to it: at the speed of evidence. Which is why I'd rather listen than talk. Three things I'm still working out, and I don't have settled answers to any of them: 1️⃣ Where AI regulation is actually landing for the teams who have to comply, not where the policy debate is 2️⃣ What MDR really cost the companies that stayed, including the products they quietly retired 3️⃣ Whether evidence generation is genuinely getting faster, or just more expensive If you work anywhere near those questions, I'd like to hear your version before I go. Comment, send me a message, or find me in Boston. I'm there 18 to 21 October, and I'll share what I learn when I'm back. Make sure to connect with our team down there. Stacey Vesterfelt Stein, Kaitlin Lerner, Melissa Pavlicek, Cathy Loe, Tyler Yehl, Scott Robertson, Sam Borgel. #MTC26 #MedTech #RegulatoryAffairs #ClinicalTrials
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Anders Horn liked thisAnders Horn liked thisA polished AI demo is not clinical evidence... and regulators know the difference immediately.⚙️ When an algorithm influences a diagnosis or guides therapy, the FDA wants proof that it performs reliably across the full range of conditions it will actually encounter. Diverse patient populations. Imaging variations. Physiological differences. Workflow pressure. Environmental noise. A controlled test environment is not that proof. In this video I break down what real-world AI validation actually requires: - Data quality and bias mitigation across representative populations - Model drift monitoring... because AI that performs well at launch can degrade silently over time - Audit trails that connect algorithm outputs to clinical decisions - Fallback modes when the AI operates outside its validated range - Human factors evidence showing clinicians can appropriately interpret and act on AI outputs - Post-market monitoring plans that satisfy ongoing regulatory expectations FDA has cleared over 1,000 AI-enabled devices. The submissions that move fastest are the ones with an evidence strategy built around real-world performance... not benchmark accuracy scores. If your AI device has strong technical performance but a thin validation strategy, this one is worth your time. 🧠 #medtechman #medtech #innovation #MedicalDevice #AIinHealthcare #SaMD
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Anders Horn liked thisAnders Horn liked thisThe Magic of Tbilisi & the Georgia Medtech Innovation Summit by Clinical Accelerator This was my first visit and I am very happy to confirm I have been in fact "clinically accelerated". What a splendid group of talent at the summit; I made many great contacts. I enjoyed my pitch with the TARR wireless monitor running on the TARR aortic recoil repair catheter in my jacket pocket, logging the device performance and status on the wireless tablet, uploading the data to the TARR patient management cloud, available for review by any clinician anywhere in the world. I had the pleasure to visit the Tbilisi Heart Center (TBHC), another site in consideration for clinical trial work. Among many talented people, I met Dr Marat Fudim, a stunning interventional heart failure doc from Duke who has a unique focus on heart failure treatments and emerging device technologies. I enjoyed meeting many clinicians, innovators, and even the strategics showed up and gave my favourite session of the gig with the penultimate session “The Exit Playbook: Lessons from MedTech Leaders on M&A, IPOs, and Value Creation”; much appreciated and thanks to Virginia Giddings, Vice President of Exploration Edwards Lifesciences; Lori Chmura, CEO Nyra Medical; Andrew Glass, CEO Vivasure Medical Gowri Raman, VP, Venture Capital Medtronic Henk Westendorp, Partner NLC Health Ventures With evidence of local wine making dating back 8000 years, the fabulous local wines were enjoyed by all, as was the incredible food and the Georgian hospitality. I already look forward to the 2027 event and spending more time in Tbilisi.
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Anders Horn liked thisAnders Horn liked thisClinical study discussion at the Biltmore between QHeart and the Tbilisi Heart Center - Georgia Medtech Innovation Summit 2026
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Anders Horn liked thisAnders Horn liked thisI'm happy to share that I've officially earned my PMP certification though Project Management Institute (PMI) ! 🎉 This certification represents more than passing an exam- It's a step towards providing more intention behind my purpose. Earning my PMP was an important addition to my project management skills, and builds more depth on my experience in operations, process improvement, and servant leadership. I'm looking forward to bring my knowleged together in this next chapter of life and continue growing. Thank you to everyone who has been so supportive of me along the way! 🤍One more goal accomplished, now onto what's next! #pmpProject Management Professional (PMP)® was issued by Project Management Institute to Lauren Mellott.Project Management Professional (PMP)® was issued by Project Management Institute to Lauren Mellott.
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EAS Consulting Group, LLC
California DTSC has proposed listing manual dish detergents and shampoos containing more than 1 ppm of 1,4-dioxane as Priority Products. If finalized, manufacturers may need to notify DTSC and either reformulate, discontinue sale in California, or conduct an Alternatives Analysis that could lead to additional requirements. The proposal could increase testing, supplier verification, and compliance obligations for affected products. The public comment period closes March 2, 2026. Details: https://hubs.ly/Q0450CxN0
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