Matthew King

Audits rarely fail because of one big issue. They fail because of repeatable patterns. This short video breaks down what FDA inspectors see most often, including: ✅ CAPA documentation gaps ✅ Incomplete training records ✅ Traceability issues between design & production If your risk files or QMS processes touch any of these areas… it’s worth a 3-minute watch. #FDA #AuditReady #QualitySystems #ISO13485 #ISO14971 #CAPA #MedTech #RegulatoryAffairs #Qualira https://zurl.co/qRzlR

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FDA: Draft Guidance: UDI Requirements for Combination Products; Guidance for Industry and FDA Staff The document is intended to assist industry and FDA staff in understanding how FDA’s (UDI) requirements at 21 CFR part 801 subpart B and part 830 subpart E apply to combination products with device constituent parts. This guidance outlines the requirements, recommendations, and best practices for UDI labeling and for submission of information to the (GUDID) for combination products. Combination products, as described in 21 CFR part 3, are comprised of two or more different types of products (i.e., a combination of a drug, device, and/or biological product with on another). Each drug, device, and biological product included in a combination product is referred to as a constituent part of the combination product. Click the link in comments ⤵️ #UNIVERSAL_UDI

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In our latest expert insight, Sarah Moore discusses why CAPA failures account for more than 30% of FDA 483 observations. The most common problem isn’t closing a non-conformity; it’s that the process doesn’t prevent recurrence. Inspectors look for proof that CAPA is fully integrated into the QMS and is driving real improvement. NSF helps manufacturers build CAPA systems that demonstrate control and withstand inspection. Learn more about our CAPA support here: https://bit.ly/3VXPmMO

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🚨NEW FDA Guidance Announcement The FDA has updated its Clinical Decision Support Software guidance, clarifying how certain CDS functions may qualify as Non Device CDS and fall outside FDA device oversight when all criteria are met. ✅The software does not acquire or analyze medical images, IVD signals, or signal patterns ✅It displays or analyzes medical information to support HCP decision making ✅It provides recommendations without replacing clinical judgment ✅It allows healthcare professionals to independently review the basis of those recommendations 𝗧𝗵𝗲𝘀𝗲 𝗱𝗶𝘀𝘁𝗶𝗻𝗰𝘁𝗶𝗼𝗻𝘀 𝗱𝗶𝗿𝗲𝗰𝘁𝗹𝘆 𝗶𝗺𝗽𝗮𝗰𝘁 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗽𝗼𝘀𝗶𝘁𝗶𝗼𝗻𝗶𝗻𝗴, 𝗰𝘆𝗯𝗲𝗿𝘀𝗲𝗰𝘂𝗿𝗶𝘁𝘆 𝗼𝗯𝗹𝗶𝗴𝗮𝘁𝗶𝗼𝗻𝘀, 𝗮𝗻𝗱 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗮𝗿𝗰𝗵𝗶𝘁𝗲𝗰𝘁𝘂𝗿𝗲. Blue Goat Cyber works with manufacturers to align CDS design, risk management, and security evidence with current FDA expectations, helping medical device companies move forward with confidence and clarity. Learn more about the change here: https://lnkd.in/dgvZac4a

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Every software medical device follows a regulatory pathway, but not every applicant knows how to map it. From defining intended use to choosing the correct risk class, from validating the algorithm to ensuring QMS traceability, each step shapes the success of your CDSCO submission. This roadmap doesn’t just outline what to file, it guides how to prepare evidence, align processes, and avoid the common pitfalls that delay approvals. When you understand the regulatory sequence, you build a stronger, more predictable compliance strategy. 📩 Visit our website: www.nkgabc.com 📧 To start your registration: navraj@nkgabc.com 📞 Call: 9711197602 . . #SaMD #SiMD #CDSCOIndia #MedicalSoftwareRegulation #RiskClassification #MDR2017 #RegulatoryStrategy #NKGAdvisory

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ATTN: U.S. Manufacturers — If you don't already have a QMSR transition plan, you're behind. The FDA's new Quality Management System Regulation (QMSR) becomes enforceable in February 2026. And while many MedTech teams already operate in alignment with ISO 13485:2016, others are just now realizing how much work sits between "generally compliant" and fully ready. QMSR isn't a minor update. It requires: ✅ Integrated risk-based thinking across every phase of the product lifecycle ✅ Harmonization with ISO 13485 (by reference) ✅ A documented, demonstrable "culture of quality" ✅ System-wide alignment, not just updated procedures If your QMS is still running on legacy documents, inconsistent ownership, or pre-COVID processes, you're not preparing… you're reacting. And with less than 18 months left, reaction time is shrinking. The good news: teams that start now will have a smoother, less costly transition, and far more control over how QMSR reshapes their operations. If you need support assessing readiness, tightening gaps, or mapping a practical plan, we're here to help: https://lnkd.in/eD2vXhsF. #QMSR #FDA #MedTechCompliance #RegulatoryStrategy

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Reminder to register for Transition from Computer System Validation (CSV) to Computer Software Assurance (CSA). This virtual seminar covers FDA’s CSA approach and practical steps for modernizing validation programs. March 4, 2026 🔗 https://hubs.ly/Q0415ky10

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Conducting Remote Regulatory Assessments Final Guidance for Industry Today, the FDA announced the availability of final guidance for industry titled Conducting Remote Regulatory Assessments Questions and Answers. The final guidance describes how FDA will use Remote Regulatory Assessments (RRAs) for FDA-regulated products. An RRA is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. Some of these tools include remote records requests, remote livestreaming video of operations, teleconferences, and screen sharing. #fda #guidance #remove #regulatory #assessment #compliance https://lnkd.in/g5FvCvHs

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Protocol deviations can happen—but understanding how FDA defines and expects them to be reported is key. Watch our on-demand Ask the IRB replay featuring Salus IRB experts MARILYN ESHIKENA and Leslie Wilson for practical insights into FDA’s draft guidance on protocol deviations. Watch now: https://lnkd.in/eSvXJr2Y

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𝗤𝗠𝗦𝗥 𝗶𝘀 𝗰𝗼𝗺𝗶𝗻𝗴—𝗮𝗻𝗱 𝗶𝘁 𝗰𝗵𝗮𝗻𝗴𝗲𝘀 𝗲𝘃𝗲𝗿𝘆𝘁𝗵𝗶𝗻𝗴. On February 2, 2026, the FDA replaces 21 CFR 820 with a regulation built directly on ISO 13485:2016. What does this mean for MedTech teams?  • Expanded FDA inspection authority  • Explicit requirements for records, complaints & UDI  • Clear rules for labeling and packaging  • Major documentation restructuring for legacy QS users If you're already ISO 13485-aligned, the impact is low. If not—now is the time to act. We break down what’s changing, who’s affected, and how to prepare in our latest Gadgeon blog : https://lnkd.in/g_MqHFRr 𝗧𝗵𝗲 𝗱𝗲𝗮𝗱𝗹𝗶𝗻𝗲 𝗶𝘀𝗻’𝘁 𝗮 𝘀𝘂𝗴𝗴𝗲𝘀𝘁𝗶𝗼𝗻. 𝗦𝘁𝗮𝗿𝘁 𝘆𝗼𝘂𝗿 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻 𝗻𝗼𝘄. #QMSR #FDA #QualityManagement #MedicalDevices #ISO13485 #MedTechRegulatory #Gadgeon #GadgeonMedTechServices 

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