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Russell Rogers reposted thisRussell Rogers reposted thisHuman factors used to be something you addressed if your device obviously called for it. That is no longer how it works. FDA finalized its human factors guidance this spring, revised the companion document on August 3, and moved submissions onto eSTAR on August 1. Together, those changes turned human factors from a question you could leave alone into a field you have to answer. The structure asks you to score your own device into one of three categories. Depending on where you land, you either justify why testing does not apply, justify partial exemption, or run the full program. Getting that self-assessment wrong tends to surface later as a deficiency, when fixing it costs the most. We broke down what the three categories mean and how to work out which one applies to your device. Read more here: https://lnkd.in/gg8j-P8N #MedicalDevices #FDA #RegulatoryAffairs #HumanFactors
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Russell Rogers reposted thisRussell Rogers reposted thisToday, we’re excited to announce the launch of Accorto Regulatory Solutions’ dedicated Quality & Compliance Division. This new division expands our ability to deliver integrated regulatory and compliance support for FDA-regulated products, including GxP compliance, quality system development, inspection readiness, and ongoing compliance activities, all aligned with regulatory strategy and FDA submissions. As client needs continue to evolve, this structure allows us to scale our quality and compliance services while maintaining the hands-on, practical approach our organization is known for. 📄 Read the full press release here: https://lnkd.in/d9WBQwkB #Accorto #RegulatoryAffairs #QualityAndCompliance #GxP #FDA #LifeSciences #Compliance
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Russell Rogers reposted thisRussell Rogers reposted 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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Russell Rogers reposted thisRussell Rogers reposted thisLooking forward to attending WHX Dubai and connecting with companies from across the global medtech and healthcare ecosystem. I’ll be there representing Accorto Regulatory Solutions, spending time with founders and teams based outside the U.S. who are thinking about or actively planning their path into the U.S. market. #WHX is a great place to have conversations about U.S. FDA strategy, clinical expectations, and what it really takes to enter the U.S. efficiently without overbuilding, overspending, or creating unnecessary risk. If you’re a company attending WHX and looking for guidance on U.S. market entry, I’d love to connect while in Dubai.
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Russell Rogers reposted thisRussell Rogers reposted thisExcited to be heading to #MD&M West in a few weeks. Especially since it’s right here in my backyard in California. I’ll be attending and representing Accorto Regulatory Solutions, spending time with founders, engineers, and teams who are building and scaling medical devices across every stage of development. If you’re going to be there and want to connect, grab a coffee, or talk shop, feel free to reach out. Looking forward to a great few days in Anaheim.
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Russell Rogers reposted thisRussell Rogers reposted thisIt's that time of year again. Hope to see everyone at MD&M.
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Russell Rogers reposted thisRussell Rogers reposted thisI’ll be in Anaheim next week for #MDMWest! Our team from Accorto Regulatory Solutions will be on-site at booth 516, helping medtech companies navigate regulatory and compliance challenges from strategy to execution. If you’re facing regulatory or compliance hurdles (or just want to sanity-check a planned approach), stop by and chat with us. We’d love to see if we can help.
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Russell Rogers shared thisLooking forward to being back at MD&M this year. We will have experts on site who will be happy to discuss how we can help you overcome your biggest regulatory challenges in 2026 - from premarket applications to manufacturing quality systems/GMP. Stop by booth 516 or setup a time using the show's app. #mdm #gmp #510k #regulatory #meddevice
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Russell Rogers reposted thisRussell Rogers reposted thisNext week I'll be in San Francisco for American Business Development's Capital Connect event during J.P. Morgan #Healthcare Conference week! Accorto Regulatory Solutions is proud to sponsor this year’s Capital Connect, and I’m looking forward to attending and connecting with innovators, investors, and industry leaders across the medtech ecosystem. At Accorto, we help medtech companies navigate the U.S. FDA with confidence, from early regulatory strategy and pathway determination through submissions, clearance, and approval. Our team partners with companies to reduce regulatory risk, align development with FDA expectations, and support efficient market entry in the U.S. If you’ll be in San Francisco for #JPMWeek or Capital Connect, I’d love to say hello!
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Congrats Tara
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Russell Rogers liked thisRussell Rogers liked 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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Russell Rogers liked thisRussell Rogers liked thisA PMTA deficiency letter usually isn't telling you that you wrote something unclearly. It's telling you the evidence isn't there. That distinction matters, because the two problems have very different fixes. One is a revision. The other can mean new studies, new timelines, and a response window that was never long enough for that kind of work. Most manufacturers respond by testing more, on the theory that more data is safer. Sometimes it is. Often it's money and months spent on studies FDA was never going to ask for, while the gap that actually triggered the letter stays open. Knowing which evidence FDA will want, before you file, is a different skill from generating as much evidence as possible. Our latest piece covers the deficiencies that come up most often and what a useful response looks like. Find out what the FDA expects here: https://lnkd.in/gt_VdG98 #PMTA #TobaccoHarmReduction #FDARegulatory #RegulatoryAffairs #NextGenerationProducts
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Russell Rogers liked thisRussell Rogers liked thisAccorto is heading to Boston for RESI, September 22 and 23 at the Westin Copley Place, part of Biotech Week Boston. RESI is where early-stage medtech, diagnostics, and digital health companies meet the investors funding them. The regulatory pathway question surfaces in nearly every one of those conversations, and it is considerably cheaper to answer before a term sheet depends on it. Anders Horn will be on site both days of RESI and in Boston for the wider Biotech Week. If you are in town for any part of the week and your FDA pathway is still an open question, he is glad to find time. Book a meeting with Anders early: https://lnkd.in/gkXcCVrS #RESIBoston #BiotechWeekBoston #MedTech #Diagnostics #RegulatoryAffairs #FDA #LifeSciences
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Russell Rogers liked thisRussell Rogers liked thisHuman factors used to be something you addressed if your device obviously called for it. That is no longer how it works. FDA finalized its human factors guidance this spring, revised the companion document on August 3, and moved submissions onto eSTAR on August 1. Together, those changes turned human factors from a question you could leave alone into a field you have to answer. The structure asks you to score your own device into one of three categories. Depending on where you land, you either justify why testing does not apply, justify partial exemption, or run the full program. Getting that self-assessment wrong tends to surface later as a deficiency, when fixing it costs the most. We broke down what the three categories mean and how to work out which one applies to your device. Read more here: https://lnkd.in/gg8j-P8N #MedicalDevices #FDA #RegulatoryAffairs #HumanFactors
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Russell Rogers liked thisRussell Rogers liked thisDay one at ADLM 2026 is a wrap. Great conversations on the exhibit hall floor, sunny skies over the convention center, and no shortage of sharp minds working through hard regulatory problems. Anders Horn and Eric Jacobson will be back on the floor tomorrow, ready for more of the same, hopefully minus another fire alarm. If you're at ADLM this week and want to talk early-stage regulatory strategy, cGMP compliance, FDA submissions, or clinical and non-clinical study planning, send a message and we'll find time to connect. #ADLM2026 #ClinicalLab
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Russell Rogers liked thisRussell Rogers liked thisAccorto has a new Marketing and Business Development Manager: Eric Jacobson. Eric spent 20 years building marketing programs in healthcare and other regulated industries, most recently driving consistent year-over-year growth for behavioral health clients through content strategy, SEO, and integrated campaigns. In this role, he's focused on making Accorto's regulatory expertise easier for the companies that need it to actually find. If you've worked with Accorto through a referral so far, that's about to get easier to do without one. #RegulatoryConsulting #FDACompliance
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Russell Rogers liked thisI’m honored to have been asked to step into the role of Vice President of Compliance Consulting, leading this new division! I’m incredibly thankful to our leadership team for believing in me and trusting me to help shape Accorto’s continued growth. I’m so excited for what’s ahead, for this division, for our clients, and for Accorto as a whole. Being here from the very beginning and watching this company grow into what it is today has been one of the most rewarding experiences of my career.Russell Rogers liked thisToday, we’re excited to announce the launch of Accorto Regulatory Solutions’ dedicated Quality & Compliance Division. This new division expands our ability to deliver integrated regulatory and compliance support for FDA-regulated products, including GxP compliance, quality system development, inspection readiness, and ongoing compliance activities, all aligned with regulatory strategy and FDA submissions. As client needs continue to evolve, this structure allows us to scale our quality and compliance services while maintaining the hands-on, practical approach our organization is known for. 📄 Read the full press release here: https://lnkd.in/d9WBQwkB #Accorto #RegulatoryAffairs #QualityAndCompliance #GxP #FDA #LifeSciences #Compliance
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R&D: In-house vs. Outsourcing—Making the Right Product Development Decision
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For US Manufacturing Companies It May Be Time To Consider On-shoring
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