Michelle Lott, RAC’s Post

𝑊𝑒 𝑝𝑙𝑎𝑛 𝑡𝑜 𝑠𝑢𝑏𝑚𝑖𝑡 𝑜𝑢𝑟 𝑈𝑆 𝐹𝐷𝐴 𝑎𝑝𝑝𝑙𝑖𝑐𝑎𝑡𝑖𝑜𝑛 𝑏𝑦 𝑀𝑎𝑟𝑐ℎ, 2024. 𝐷𝑜 𝑤𝑒 𝑛𝑒𝑒𝑑 𝑡𝑜 𝑐𝑜𝑛𝑠𝑖𝑑𝑒𝑟 𝑄𝑀𝑆𝑅? When you put your product application into the FDA, there is no expectation that you have a full quality management system until you go into commercialization. So technically, if you submit in 2025 and you get cleared in 2025 and you commercialize in 2025, you need to be compliant only with the QSR. But then right on the heels of that in February 2026, you're going to have to be compliant with the QMSR. Given that the average 510(k) review time is about 200 days, it would be wise to comply with QMSR right out of the gate. If you're compliant with QMSR, you're compliant with QSR, but if you're only compliant with QSR, you'll be out of compliance with QMSR. It will take you less time and effort to just align your quality management system with QMSR from the start, and not have the rework it a few months later. ------------------------------------------------------------------------------------ Hi! I'm Michelle, and I believe that a strong regulatory strategy can be a huge competitive advantage – and quite possibly fun to develop.  So if you're tired of dealing with regulatory submissions, audit preparation and remediation, due diligence, quality systems, and more, break out the tequila and give me a call! https://leanraqa.com/time #medicaldevices #regulatoryaffairs #compliance #FDA #startups #510k #medtech #biotech #submissions #qualitymanagement

The FDA’s new Quality Management System Regulation (QMSR) is here! Published on January 31, 2024, and effective February 2, 2026, this regulation marks a significant shift in how medical device companies must operate. Our new blog series is designed to guide you through the transition. Our first article breaks down the changes and provides practical steps to help your company comply. Don't wait until it’s too late—start preparing now. Read the first post in the series today! 👉 https://lnkd.in/eqD38nWT #MedicalDevices #QMSR #QualityManagement #FDACompliance #RegulatoryAffairs #ComplianceArchitects

Establishing a quality management system (QMS) is often seen as a burden—or at least a fairly high hurdle for medical device startups to get over. 😧 The truth is that your QMS is a vital part of your organization’s success. And while it is a regulatory requirement, it may not be as difficult to build as you think. 🤔 Whether your company has an established QMS or you’re just beginning your journey, this guide should help you as you consider where to start or what gaps you need to fill. 🚀 Here's where to begin: https://hubs.ly/Q02JbB1t0. #qsr #qualitymanagement #qualitymanagementsystem #qms #fda #iso13485 #qmsr #ggquality #greenlightguru

Excellent article by my colleague John Daley on the latest FDA regulation changes for the MedTech industry!

𝐇𝐚𝐯𝐞 𝐲𝐨𝐮 𝐞𝐯𝐞𝐫 𝐟𝐞𝐥𝐭 𝐭𝐡𝐞 𝐨𝐯𝐞𝐫𝐰𝐡𝐞𝐥𝐦𝐢𝐧𝐠 𝐩𝐫𝐞𝐬𝐬𝐮𝐫𝐞 𝐨𝐟 𝐚 𝐥𝐨𝐨𝐦𝐢𝐧𝐠 510(𝐤) 𝐬𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐝𝐞𝐚𝐝𝐥𝐢𝐧𝐞, 𝐚𝐥𝐥 𝐰𝐡𝐢𝐥𝐞 𝐣𝐮𝐠𝐠𝐥𝐢𝐧𝐠 𝐭𝐡𝐞 𝐞𝐧𝐝𝐥𝐞𝐬𝐬 𝐭𝐚𝐬𝐤𝐬 𝐨𝐟 𝐌𝐞𝐝𝐓𝐞𝐜𝐡 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭? This scenario is all too common in our industry, particularly for startups where resources are limited and the value of every moment is amplified. Reflecting on my journey, the process of submitting for FDA clearance was a monumental task that overshadowed our other critical work as a startup. Yet, through dedicated, structured efforts and the invaluable support of our regulatory agent, we triumphed. This journey through the 510(k) submission process was more than a meticulous exercise in attention to detail; it was a strategic voyage through the complexities of regulatory requirements, ensuring our innovative solution swiftly reached the market. This experience served as a potent reminder of the critical role that specialized focus plays in transforming regulatory challenges into milestones of success. 𝐈𝐟 𝐲𝐨𝐮'𝐫𝐞 𝐜𝐮𝐫𝐫𝐞𝐧𝐭𝐥𝐲 𝐟𝐚𝐜𝐢𝐧𝐠 𝐭𝐡𝐞 𝐢𝐧𝐭𝐫𝐢𝐜𝐚𝐜𝐢𝐞𝐬 𝐨𝐟 𝐚 510(𝐤) 𝐬𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐟𝐨𝐫 𝐲𝐨𝐮𝐫 𝐬𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐚𝐧𝐝 𝐚𝐫𝐞 𝐟𝐞𝐞𝐥𝐢𝐧𝐠 𝐨𝐯𝐞𝐫𝐰𝐡𝐞𝐥𝐦𝐞𝐝, I'm here to offer relief. Driven by a passion for bringing innovative solutions to fruition, I provide guidance and hands-on support designed to make your submission process as smooth and efficient as possible. How do you manage the stress and complexity inherent in regulatory submissions? I invite you to share your experiences or reach out directly. Together, we can turn your regulatory hurdles into stepping stones for growth and success. #MedTech #FDAsubmission #510k #RegulatoryAffairs #HealthTech #StartupLife #Innovation #MedicalDevices #QualityAssurance #RegulatoryCompliance Kader

You know that regulatory compliance is a critical investment regardless of the target market. But launching a product in some markets may not make good fiscal $en$e.   MDR certification fees can run as high as $100K per product, potentially exceeding five-year revenue projections for new products.   And it's not just the EU that's pricey - a de novo or PMA submission with the FDA can run about $91K per product.   Frustrated? You're not alone. This new paradigm has upset the market entry plans of many companies who now must determine whether the sizable initial investment is worth it.   So we've created this free Business Market Assessment tool to help you help you understand the initial investment and recurring costs you'll face complying with the regulatory requirements for your chosen market.   This free guide walks you through revenue vs. cost modeling calculations to help you judge the market viability of your product and see if MDR certification or FDA approval makes $en$e – before you commit.   So, download it here and share this link with anyone else who might appreciate it: https://lnkd.in/ggHdfw9C   Still not sure? Put some time on my calendar and we'll chat - about this or any other pressing regulatory or quality issue you may have.   ------------------------------------------------------------------------------------ Hi - I'm Michelle, and I believe that a strong regulatory strategy can be a huge competitive advantage – and quite possibly fun to develop.  So if you're tired of dealing with regulatory submissions, audit preparation and remediation, due diligence, quality systems, and more, break out the tequila and give me a call! 🍸  #medicaldevices #regulatoryaffairs #compliance #FDA #startups #510k #medtech #biotech #submissions #qualitymanagement

Some quality "quality" help on the medical side available for those in need ! Turns out ISO 13485 + FDA isn't that difficult if you know what you are doing. #serialentrepreneur #founder #founders #techentrepreneur #medicaldevices #techstartups #startup #startups #leanstartup #leanstartups #embeddedsystems #engineering #innovation #technology #future #homeofcool

Are you a medical device company looking for cost-effective quality and regulatory support? Navigating the complex world of medical device regulations and quality standards can be daunting. Whether you're scaling a startup, entering new markets, or maintaining compliance for existing products. Expert support can make all the difference, and we can provide you with this support cost-effectively. 💡 Here’s how we can help: ✅ Tailored regulatory strategies for FDA, CE UKCA Mark, and global market entry ✅ Quality Management System (QMS) implementation and optimisation ✅ End-to-end guidance on ISO 13485, MDR, IVDR, and more ✅ Hassle-free audit preparation and gap analysis ✅ Post-market surveillance and risk management solutions QAEC Limited brings decades of expertise in the medical device industry, partnering with companies of all sizes to achieve compliance efficiently without breaking your budget. Whether you're a startup looking for a roadmap or an established company needing to streamline processes, we're here to support your growth. 👉 Ready to simplify your quality and regulatory journey? Message me at Charles (Ed) Spearpoint or visit https://qaeclimited.co.uk/ to learn more. Let’s ensure your devices reach the market safely, quickly, and cost-effectively. #MedicalDevices #RegulatoryCompliance #QualityManagement #Consulting #MedicalTechnology #ISO13485 #MDR #FDA #QAECLimited #CEMarking #UKCAMarking #QMS #IVDR #IVD #PMS #PostMarketSurveilance #RiskManagement #RegulatoryRoadMap

It was an honor to share a panel discussing the FDA’s new Quality Management System Regulation and it’s implications for medical device and combination product manufacturing with industry experts Marnie Smith and Jackie Torfin at #MDMMinneapolis. Also, a special “thank you” to Mark Swanson - your encyclopedic knowledge of standards and regulations never ceases to amaze me! 🤯   If you are medical device manufacturer and you have questions concerning the QMSR – the time to act is now! The QMSR will come into enforcement February 2026 and if we learned anything from the EU MDR transition it is that deadlines come faster than we think. Contact me directly for complementary QMSR educational materials and we can discuss how to prepare your organization for compliance to this new regulation. [email protected] #QMSR #Quality #Regulatory #MedicalDevice

What is RegulatoryThinking? - Part 1: The Regulatory Perspective In the dynamic world of medical devices and IVDR, 'RegulatoryThinking' is often the cornerstone of successful product development and market entry. But what does it really involve? 🔍 Foundational Elements: RegulatoryThinking is not just about compliance; it's a proactive approach to integrating regulatory frameworks into every phase of product lifecycle management. It's about understanding how these regulations affect your product from concept to market and beyond. 📜 Why It Matters: Compliance from Day One: By embedding regulatory requirements into the design phase, companies can avoid costly revisions and delays. It's about foreseeing regulatory hurdles and planning strategically to navigate them effectively. Global Standards Alignment: Whether it's FDA approvals in the U.S., CE marking in Europe, or PMDA approvals in Japan, RegulatoryThinking helps align your product development with international standards, simplifying global market access. Continuous Monitoring: Regulatory landscapes are ever-evolving. Proactive regulatory monitoring ensures that your product remains compliant as new laws and standards emerge, safeguarding your market position. 🔄 Keeping Pace with Technology: Regulations, standards and norms reach back into the past and are based on established technologies. Modern concepts and future innovations often lack a specific framework. RegulatoryThinking is committed to applying existing standards to these new technologies in a transparent and logical approach: This approach extends these standards to new developments to guide and support the responsible integration of disruptive technologies into society, ensuring both progress and safety. 🌐 A Strategic Approach: At its core, RegulatoryThinking is strategic. It requires an intricate understanding of not only current laws but also pending regulations and industry trends that could affect your product's lifecycle. This holistic view ensures that innovation and compliance go hand in hand, reducing risk and enhancing market readiness. 🔗 Stay Tuned for Part 2, where we'll explore how RegulatoryThinking extends beyond mere compliance—incorporating essential business planning, reimbursement strategies, and overall market success. 💬 Let's Discuss! How do you integrate RegulatoryThinking into your product development processes? Have you experienced benefits from early regulatory involvement? Share your thoughts and experiences below!