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🔊 𝗖𝗮𝗹𝗹𝗶𝗻𝗴 𝗔𝗹𝗹 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗜𝗻𝘃𝗲𝘀𝘁𝗼𝗿𝘀! At QRx Partners, we help early-stage MedTech startups turn great ideas into products that improve patients' lives. Our team builds the quality and regulatory strategies investors look for—clear plans, credible timelines, a path to market release. We do this by working with companies that recognize the value of planning to ensure success, often with early FDA feedback that accelerates market approval. That means when you connect with QRx, you’re tapping into a network of startups that have already been 𝘃𝗲𝘁𝘁𝗲𝗱 𝗳𝗼𝗿 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗿𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀 and are ready to move fast once funding is secured. If you’re an 𝗶𝗻𝘃𝗲𝘀𝘁𝗼𝗿 seeking high-potential MedTech opportunities, partner with us to strengthen your probable 𝘀𝘂𝗰𝗰𝗲𝘀𝘀. Together, we can help innovative founders get the funding they need to get to market to help patients—and help you invest with confidence. 🤝 👉 𝗟𝗲𝘁’𝘀 𝗰𝗼𝗻𝗻𝗲𝗰𝘁 𝘁𝗼 𝗮𝗹𝗶𝗴𝗻 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻, 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝘆, 𝗮𝗻𝗱 𝗰𝗮𝗽𝗶𝘁𝗮𝗹. Message QRx Partners Steve Gompertz or Mark Swanson to start the conversation, or send us a note through our website 📧 https://lnkd.in/gH9Cfinp #QRxPartners #QRxInforms #InvestmentOpportunity #MedTech #StartUp #capital #investor #MedTechInvestment

Sign up today for QRx Partners' next complimentary quarterly webinar with QRx Partners Mark Swanson & Steve Gompertz! Scroll for more info ... "After three years, the FDA finalized this guidance that clarified the application of risk-based thinking to validation of the systems companies use to manage production and their QMS. In this webinar, QRx Partners Steve Gompertz and Mark Swanson will review the basic concepts and clarify what changed in the final version compared to the 2022 draft. Not to be missed, as under-and over-validation of these systems is very common in the MedTech industry." Register here 👉 https://lnkd.in/gtUYG4Z6 #QRxPartners #QRxInforms #webinar #FDAcompliance #FDA #QMS #MedTech

🔊 𝗖𝗮𝗹𝗹𝗶𝗻𝗴 𝗔𝗹𝗹 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗜𝗻𝘃𝗲𝘀𝘁𝗼𝗿𝘀! At QRx Partners, we help early-stage MedTech startups turn great ideas into products that improve patients' lives. Our team builds the quality and regulatory strategies investors look for—clear plans, credible timelines, a path to market release. We do this by working with companies that recognize the value of planning to ensure success, often with early FDA feedback that accelerates the review for placing the product on the market. That means when you connect with QRx, you’re tapping into a network of startups that have already been 𝘃𝗲𝘁𝘁𝗲𝗱 𝗳𝗼𝗿 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗿𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀 and are ready to move fast once funding is secured. If you’re an 𝗶𝗻𝘃𝗲𝘀𝘁𝗼𝗿 seeking high-potential MedTech opportunities, partner with us to strengthen your probable 𝘀𝘂𝗰𝗰𝗲𝘀𝘀. Together, we can help innovative founders get the funding they need to get to market to help patients—and help you invest with confidence. 🤝 👉 𝗟𝗲𝘁’𝘀 𝗰𝗼𝗻𝗻𝗲𝗰𝘁 𝘁𝗼 𝗮𝗹𝗶𝗴𝗻 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻, 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝘆, 𝗮𝗻𝗱 𝗰𝗮𝗽𝗶𝘁𝗮𝗹. Message QRx Partners Steve Gompertz or Mark Swanson to start the conversation, or send us a note through our website 📧 https://lnkd.in/gH9Cfinp #QRxPartners #QRxInforms #InvestmentOpportunity #MedTech #StartUp #capital #investor #MedTechInvestment

🔊 𝗖𝗮𝗹𝗹𝗶𝗻𝗴 𝗔𝗹𝗹 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗜𝗻𝘃𝗲𝘀𝘁𝗼𝗿𝘀! At QRx Partners, we help early-stage MedTech startups turn great ideas into products that help patients. Our team builds the quality and regulatory strategies investors look for—clear plans, credible timelines, a path to market release. We do this by working with companies that recognize the value of planning to ensure success, often with early FDA feedback that accelerates the review for placing the product on the market. That means when you connect with QRx, you’re tapping into a network of startups that have already been 𝘃𝗲𝘁𝘁𝗲𝗱 𝗳𝗼𝗿 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗿𝗲𝗮𝗱𝗶𝗻𝗲𝘀𝘀 and are ready to move fast once funding is secured. If you’re an 𝗶𝗻𝘃𝗲𝘀𝘁𝗼𝗿 seeking high-potential MedTech opportunities, partner with us to strengthen your probable 𝘀𝘂𝗰𝗰𝗲𝘀𝘀. Together, we can help innovative founders get the funding they need to get to market to help patients—and help you invest with confidence. 🤝 👉 𝗟𝗲𝘁’𝘀 𝗰𝗼𝗻𝗻𝗲𝗰𝘁 𝘁𝗼 𝗮𝗹𝗶𝗴𝗻 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻, 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝘆, 𝗮𝗻𝗱 𝗰𝗮𝗽𝗶𝘁𝗮𝗹. Message QRx Partners Steve Gompertz or Mark Swanson to start the conversation, or send us a note through our website 📧 https://lnkd.in/gH9Cfinp #QRxPartners #QRxInforms #InvestmentOpportunity #MedTech #StartUp #capital #investor

🖋️ When teaching about preparing for inspections and audits, 𝘄𝗲 𝗿𝗲𝗳𝗲𝗿 𝘁𝗼 𝘄𝗵𝗮𝘁 𝘄𝗲 𝗰𝗮𝗹𝗹 𝘁𝗵𝗲 "𝗽𝗹𝗲𝗮𝘀𝗲 𝗱𝗶𝗴 𝗵𝗲𝗿𝗲" 𝗳𝗹𝗮𝗴. 🚩 Sometimes seemingly small observations that cause the inspector or auditor to start asking more questions and heading down a path they might otherwise have missed. In this week's Warning Letter, these flags were Complaint records. Unfortunately, it wasn't just one flag that caught FDA's attention, there were several at three different sites worldwide; making these flags more of a mandate than a hint. Once they started digging, they found: 🚩A CAPA process that couldn’t be relied upon 🚩CAPAs that were never initiated 🚩CAPAs that were closed without completing promised actions In multiple cases, the same issues reappeared across complaints—without anyone seeming to notice the trend. Even worse, some investigations were handled outside the formal QMS entirely. 😲 That’s right—bypassing the system designed to ensure traceability and control. As the FDA continued to dig, CAPA led to Design Controls where validation of design changes was found to be lacking. 🛑 From there it was a dive into Acceptance Activities as there were indications of a component failure contributing to the Complaint trends stemming from inadequate inspection of internally supplied components. All 3️⃣ sites provided timely responses addressing dozens of observations in total. Unfortunately, only 2️⃣ were deemed sufficient to allow the FDA to determine their adequacy. In other words, while proposed actions made sense, the company didn't provide enough evidence yet of their implementation or effectiveness. Ultimately, the company undertook what amounted to multiple device recalls. And unfortunately, they failed to notify the FDA within the required time frames. 🫣 And just to make things worse, all of those responses provided by the three sites, forgot to cover these reporting violations. 👉 Establishing an effective QMS starts with understanding the importance of the word "System". Your QMS isn't just a pile of procedures. It's supposed to be a system of interconnected processes. 👈 If you don't connect the processes, the FDA will connect them for you. And again, the quality of your response to FDA observations, greatly determines what steps the FDA will take next. In both cases, establishing an effective QMS and responding to observations of nonconformance, expert guidance would make the difference between success and public embarrassment (not to mention danger to patients and users). Read the full FDA Warning Letter here 👉 https://lnkd.in/gCk2Ybu9 Want to hear more FDA Warning Letter analysis with the QRx Partners Steve Gompertz and Mark Swanson? Click here ▶️ https://lnkd.in/gUc9GixQ #QRxPartners #QRxInforms #InadequateResponse #FDA #QMS #CAPA #CDRH

🖋️ We've written several times about Warning Letters where huge portions of the QMS were missing, but we've never seen one where the entire QMS was missing. 😬 This week's Warning Letter wasn't for some low-risk device where GMP exemption wasn't clear. This involves Class II high-tech wheelchairs, including those designed for children and for facilitating a standing position. The latter is particularly risky because if a fall were to occur, the distance to the ground or angular momentum is greater, representing significantly more energy imparted on the patient. Understanding those increased risks is exactly why robust Design Controls and Risk Management are required. 🛑 Except, not only were there no Design Control processes established, there were no QMS processes established at all; none! Yes, every subpart of 21 CFR Part 820 was missing❗ And every required document and record. It must have been one of the shortest FDA inspections in history. The company responded to the inspectional observations with a CAPA for each missing process. What's funny about that is how did they initiate CAPAs without a CAPA process in place? 🤔 Regardless, they must have been well written CAPAs as the FDA didn't respond with the dreaded, "Your response is inadequate." Instead, they noted only that the adequacy of their response couldn't be determined. Basically, that means that the FDA agrees with the plan and will wait to see the results. The company also did the right thing by voluntarily suspending all export of their devices to the U.S. Although the FDA also put them on "Detention Without Physical Examination" so that anything hitting U.S. Customs will be automatically rejected. One learning opportunity, beyond the obvious, related to responding to the Warning Letter when the FDA has essentially agreed with the corrective action plans, is that you should respond with clear updates on progress made and examples of the resulting outputs. 👈 Timing wise, the original response was provided to the FDA in April 2025. So, significant progress should have occurred, i.e. - hopefully the company wasn't waiting on feedback from the FDA to begin executing the plans. We're always here for any questions or advice 🤝 https://lnkd.in/gH9Cfinp Read the full FDA Warning Letter here 👉 https://lnkd.in/g6cDE_9c Want to hear more FDA Warning Letter analysis with the QRx Partners Steve Gompertz and Mark Swanson? Check out their latest quarterly "Inadequate Response" video discussion! ▶️ https://lnkd.in/g4ed7XKi #QRxPartners #QRxInforms #InadequateResponse #FDAcompliance #QMS #CAPA #CDRH #MedicalDevices #FDAWarningLetters #regulatory #MLV