{"id":8813,"date":"2026-02-18T19:10:49","date_gmt":"2026-02-18T19:10:49","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=8813"},"modified":"2026-02-18T19:36:54","modified_gmt":"2026-02-18T19:36:54","slug":"key-regulatory-references-for-the-fda-medical-device-inspection-compliance-program","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/key-regulatory-references-for-the-fda-medical-device-inspection-compliance-program\/","title":{"rendered":"Key Regulatory References for the FDA Medical Device Inspection Compliance Program"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8813\" class=\"elementor elementor-8813\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4264d41\" data-id=\"4264d41\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-e193c4d\" data-id=\"e193c4d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2026\/02\/18\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tFebruary 18, 2026\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">Key Regulatory References for the FDA Medical Device Inspection Compliance Program<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78a7c7e elementor-widget elementor-widget-image\" data-id=\"78a7c7e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"760\" height=\"508\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/two-persons-reviewing-labels-product-e1690296466837.jpg\" class=\"attachment-full size-full wp-image-6276\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/two-persons-reviewing-labels-product-e1690296466837.jpg 760w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/two-persons-reviewing-labels-product-e1690296466837-300x201.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/two-persons-reviewing-labels-product-e1690296466837-500x334.jpg 500w\" sizes=\"(max-width: 760px) 100vw, 760px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fc2ca86 elementor-widget elementor-widget-text-editor\" data-id=\"fc2ca86\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p><strong>Introduction<\/strong><br \/>FDA has released the Inspection of Medical Device Manufacturers Compliance Program 7382.850, effective February 2, 2026, formally replacing the long-standing Quality System Inspection Technique (QSIT). That alone is a big deal. Combined with the rollout of the Quality Management System Regulation (QMSR), it signals a very real shift in how FDA expects manufacturers to think about, operate, and defend their quality systems.<br \/>While QMSR has been discussed for some time, the inspection implications are just now landing. Inspections are becoming more focused on risk-based decision making throughout the quality system to evaluate whether processes and operations work, day in and day out.<br \/>This blog post gets straight to the point: We focus on what the new inspection compliance program means in practice and begin with a concise QMSR refresher to set the stage.<br \/>________________________________________<br \/><strong>QMSR Explained Simply<\/strong><br \/>At its core, QMSR replaces FDA\u2019s legacy Quality System Regulation with a framework that better reflects how modern quality systems are expected to function. The goal is not to do more paperwork; rather, the goal is better alignment, clearer accountability, and stronger risk-based decision making.<\/p><p>Manufacturers had ample opportunity to prepare for QMSR. Rather than rehashing the full comparison of QMSR vs. QSR here, we recommend reviewing the ELIQUENT blog \u201c<a href=\"https:\/\/eliquent.com\/qmsr-resources\/\">From QSR to QMSR: What\u2019s Changing and Why It Matters<\/a>\u201d that walks through QMSR versus the prior regulation in detail.<br \/>What feels familiar under QMSR are the fundamentals: design controls, CAPA, supplier controls, complaint handling, and internal audits. What has changed: There is now a heightened expectation that these processes operate as a connected system informed by risk and actively overseen by management.<br \/>This distinction matters, because it is foundational to an effective quality management system \u2013 one that consistently supports safe and effective medical devices. FDA inspections tend to reveal whether that foundation is truly in place. ________________________________________<\/p><p><strong>Inspection of Medical Device Manufacturers Compliance Program<\/strong><br \/><strong>Purpose of the Program<\/strong><\/p><p>The Inspection of Medical Device Manufacturers Compliance Program defines how FDA investigators plan and conduct quality system inspections. It provides a structured approach for evaluating whether a manufacturer\u2019s quality system is designed and implemented to consistently meet regulatory requirements.<br \/>The program is not intended to be a simple checklist \u2013 its purpose is to assess system integrity, risk control, and the manufacturer\u2019s ability to identify and address issues proactively.<br \/><strong>High Level Inspection Structure and Intent<\/strong><br \/>While the updated compliance program replaces QSIT, it does not fundamentally change the overall structure of FDA medical device establishment inspections. Investigators will continue to assess core quality system processes using a risk-based approach, with flexibility to adjust depth and focus based on product risk, compliance history, and observed system performance.<br \/>The significance of the update is less about inspection mechanics and more about how investigators interpret and connect quality system activities under QMSR.<\/p><p><strong>What Investigators Are Evaluating<\/strong><br \/>At the quality system level, investigators are evaluating:<\/p><ul><li>How risks are identified, assessed, and controlled<\/li><li>Whether processes operate as described<\/li><li>How data is used to monitor performance<\/li><li>How management responds to signals of nonconformance or drift<\/li><\/ul><p>The inspection experience increasingly evaluates how the quality management system behaves under real world conditions.<br \/>________________________________________<br \/><strong>How QMSR Changes the Inspection Experience<\/strong><br \/>Inspections are at the heart of the change. QMSR may be a regulation, but inspections are where it becomes real.<\/p><p><strong>From Discrete Subsystems to an Integrated View<\/strong><br \/>This is where many teams get surprised.<br \/>Under QSIT, inspections often felt compartmentalized. Design controls were reviewed separately from CAPA, supplier controls, or postmarket activities. While linkages existed, they were not always explored deeply unless a specific issue triggered further review.<\/p><p>Under QMSR, investigators are more intentionally connecting processes. Discussions are increasingly centered on how information flows across the quality system. A design issue may lead directly to risk management, complaint trending, CAPA prioritization, and management review discussions.<br \/>Manufacturers should expect fewer isolated questions and more end-to-end conversations about how issues are identified, assessed, escalated, and resolved.<br \/><strong>Inspection reality:<\/strong> Investigators are following the story, not just the flowchart utilized with QSIT.<br \/><strong>Greater Emphasis on Risk-Based Decision Making<\/strong><br \/>If risk management lives in a file instead of driving decisions, it will show.<\/p><p>Risk management is no longer treated as a standalone activity or a static file. Investigators are evaluating how risk-based thinking influences day-to-day decisions across the organization. This includes:<\/p><ul><li>How risks inform design changes and validation activities<\/li><li>How complaint and nonconformance data feed risk assessments<\/li><li>How CAPA actions are prioritized based on patient, user, and product risk<\/li><li>How risk-based decision making permeates throughout quality management system operations and processes<\/li><\/ul><p>Organizations that cannot clearly explain why certain risks were accepted, mitigated, or deprioritized may struggle, even if documentation appears complete.<br \/><strong>Focus on Effectiveness Over Formal Compliance<\/strong><br \/>Documenting a process is necessary to comply with FDA and other regulatory bodies, but demonstrating a process\u2019s effectiveness is what matters. QMSR shifts inspection emphasis away from procedural completeness toward system effectiveness. Investigators are asking whether processes work as intended. Examples include:<\/p><ul><li>Whether corrective actions prevent recurrence instead of just closing issues on time<\/li><li>Whether supplier controls detect and manage incoming material variability before it impacts product<\/li><li>Whether internal audits identify meaningful issues or simply confirm basic compliance<\/li><\/ul><p>Well-written procedures are no longer sufficient on their own. The expectation is that outcomes will demonstrate control.<\/p><p><strong>Increased Scrutiny of Management Oversight<\/strong><br \/>Leadership engagement is no longer assumed. It is evaluated.<br \/>Management responsibility is central under QMSR, and inspections reflect that. Investigators are spending more time evaluating how leadership governs the quality system. This includes assessing:<\/p><ul><li>The quality and use of management review inputs<\/li><li>How quality metrics drive decisions and resource allocation<\/li><li>How leadership responds to emerging risks and system signals<\/li><\/ul><p>Management review that functions as a reporting exercise, rather than a decision-making forum, is increasingly visible during inspections.<br \/><strong>Inspection Conversations Are Now More Narrative<\/strong><br \/>This is another area where teams often underestimate the shift.<br \/>Investigators are building narratives across inspection activities rather than just checking individual requirements. Teams are being asked to explain how their quality system operates in practice, how issues are handled when things go wrong, and how learning is fed back into the system.<br \/>Organizations that prepare teams to coherently explain processes, decisions, and rationale are better positioned than those that focus solely on document availability.<br \/>________________________________________<\/p><p><strong>Key Differences Between QSIT and the QMSR<\/strong> Inspection Approach<br \/>The table below summarizes the inspection approach under QSIT compared to inspections aligned with QMSR expectations. While FDA inspection fundamentals remain, the lens through which investigators evaluate quality systems has clearly shifted.<\/p><table><tbody><tr><td><p><strong>Inspection Dimension<\/strong><\/p><\/td><td><p><strong>QSIT-Based Inspection Approach<\/strong><\/p><\/td><td><p><strong>QMSR-Aligned Inspection Approach<\/strong><\/p><\/td><\/tr><tr><td><p><strong>Overall focus<\/strong><\/p><\/td><td><p>Verification of compliance with defined subsystems and requirements<\/p><\/td><td><p>Evaluation of overall quality system performance and effectiveness<\/p><\/td><\/tr><tr><td><p><strong>Structure<\/strong><\/p><\/td><td><p>Linear review of discrete subsystems<\/p><\/td><td><p>Integrated, end-to-end assessment across processes<\/p><\/td><\/tr><tr><td><p><strong>Use of risk management<\/strong><\/p><\/td><td><p>Often reviewed as a standalone activity, primarily tied to design<\/p><\/td><td><p>Reflected through risk-based process controls and decision making across the quality system<\/p><\/td><\/tr><tr><td><p><strong>Documentation emphasis<\/strong><\/p><\/td><td><p>Heavy focus on procedures and records<\/p><\/td><td><p>Focus on whether documentation reflects real-world practice<\/p><\/td><\/tr><tr><td><p><strong>Decision-making rationale<\/strong><\/p><\/td><td><p>Confirmation that required steps were followed<\/p><\/td><td><p>Examination of why decisions were made and how risk was weighed<\/p><\/td><\/tr><tr><td><p><strong>CAPA evaluation<\/strong><\/p><\/td><td><p>Emphasis on timely closure and documentation<\/p><\/td><td><p>Emphasis on root cause quality and prevention of recurrence<\/p><\/td><\/tr><tr><td><p><strong>Management involvement<\/strong><\/p><\/td><td><p>Management responsibility generally implied<\/p><\/td><td><p>Management oversight actively evaluated and discussed<\/p><\/td><\/tr><tr><td><p><strong>Inspection conversations<\/strong><\/p><\/td><td><p>Requirement-driven and transactional<\/p><\/td><td><p>Narrative-driven, connecting signals across the system<\/p><\/td><\/tr><\/tbody><\/table><p>For organizations accustomed to QSIT-based inspection preparation, this comparison highlights why inspection readiness under QMSR requires more than just updating procedures \u2013 teams must be able to explain how their quality system operates as a cohesive, risk-informed unit.<br \/>________________________________________<\/p><p><strong>Common Readiness Gaps Seen Across the Industry<\/strong><br \/>Readiness gaps are not new problems. QMSR simply makes them far more visible.<br \/>Across industry, the same issues continue to surface during inspections. QMSR does not create these gaps, but it does make it harder to hide.<br \/><strong>Documentation That Does Not Reflect Practice<\/strong><br \/>One of the most common gaps is misalignment between documented procedures and actual operations. Investigators quickly identify when practices have evolved but documentation has not. This gap erodes credibility and invites deeper inspection.<\/p><p><strong>Risk Management Operating in Silos<\/strong><br \/>Risk management is often treated as a design phase activity rather than a living process. When risk files are disconnected from complaints, CAPA, or supplier issues, it signals weak system integration.<br \/><strong>Weak Management Oversight and Governance<\/strong><br \/>Another frequent finding involves management review that focuses on metrics without clear decisions or follow up actions. Under QMSR, leadership accountability is central, not symbolic.<br \/>________________________________________<br \/><strong>Practical Preparation Strategies<\/strong><br \/>Strong inspection outcomes start long before FDA arrives. Good preparation under QMSR is less about rewriting procedures and more about strengthening how the organization operates.<br \/><strong>Assess Readiness Now<\/strong><br \/>Organizations should conduct structured QMSR readiness assessments that evaluate not only compliance gaps but also system effectiveness. This includes reviewing how processes interact and how decisions are made.<br \/>Early assessments allow time to correct foundational issues rather than being forced to react under inspection pressure.<\/p><p><strong>Prepare People and Processes, Not Just Documents<\/strong><br \/>Effective preparation includes:<\/p><ul><li>Training leadership on QMSR expectations and inspection dynamics<\/li><li>Reinforcing risk\u2011based thinking across functions<\/li><li>Conducting realistic internal audits that test system performance<\/li><\/ul><p>Inspection readiness depends as much on how teams respond to questions as on what is written.<br \/>________________________________________<br \/><strong>Conclusion<\/strong><\/p><p>QMSR and the retirement of QSIT represent a real shift in how FDA evaluates medical device quality systems. Inspections are now more focused on system performance, risk-based decision making, and visible leadership oversight. Organizations that deliberately prepare for inspections are better positioned to navigate those inspections with confidence and will avoid reacting under pressure. <br \/>ELIQUENT supports medical device manufacturers at every stage of this transition, combining regulatory depth with hands-on inspection experience.<br \/>For organizations looking to build awareness and alignment quickly, ELIQUENT offers a <em><strong>1-day FDA QSR to QMSR Transition Training<\/strong><\/em> class designed to help teams understand what is changing, what is not, and how inspection expectations are evolving.<br \/>For teams seeking a deeper, system-level understanding, ELIQUENT\u2019s <em><strong>3-day QMS, ISO 13485, and FDA QMSR Training<\/strong><\/em> class provides comprehensive instruction on building and sustaining an integrated, inspection-ready quality management system.<br \/>Beyond training, ELIQUENT provides <strong>quality system audit and consulting services<\/strong> to help organizations assess QMSR readiness, prepare for FDA inspections, and strengthen quality system effectiveness before, during, and after an inspection.<\/p><p>Whether you are just starting your QMSR transition or preparing for an upcoming FDA inspection under the new inspection approach, ELIQUENT can partner with your team to turn regulatory change into practical, sustainable improvement.<br \/>________________________________________<br \/><em>This article reflects ELIQUENT Life Sciences\u2019 interpretation and application of publicly available FDA regulations and inspection frameworks, informed by extensive hands-on inspection and quality system experience.<\/em><br \/><strong>References<\/strong><\/p><p><strong>1. From QSR to QMSR: What\u2019s Changing and Why It Matters<br \/><a href=\"https:\/\/eliquent.com\/qmsr-resources\/\">https:\/\/eliquent.com\/qmsr-resources\/<\/a><br \/><\/strong><\/p><p><strong>2. It&#8217;s Here! FDA QSR vs. QMSR: What Medical Device Manufacturers Need to Know<br \/><a href=\"https:\/\/www.orielstat.com\/blog\/fda-qsr-vs-qmsr\/\">https:\/\/www.orielstat.com\/blog\/fda-qsr-vs-qmsr\/<\/a> <\/strong><\/p><p><strong>3. 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Cause Analysis<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-27\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/clinical-evaluation-reports\/\">Clinical Evaluation Reports<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-59\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/combination-products\/\">Combination Products<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-23\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/complaint-handling-postmarket-surveillance\/\">Complaint Handling and PMS<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-33\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/design-control\/\">Design Control<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-34\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/in-vitro-diagnostics-ivdr\/\">EU IVDR (2017\/746)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-16\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/eu-medical-device-regulation\/\">EU MDR (2017\/745)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-14\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/us-fda-qsr\/\">FDA 21 CFR Part 820<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-21\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/510k-submissions\/\">FDA 510(k) Submissions<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-69\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/fda-eua\/\">FDA EUA<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-4\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/iso-134852016\/\">ISO 13485 QMS Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-30\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/risk-management-iso14971\/\">ISO 14971 Risk Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-40\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/laboratory-developed-tests-ldt\/\">Lab Developed Tests<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-66\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-31a1563 elementor-widget elementor-widget-text-editor\" data-id=\"31a1563\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3dc6bf9 elementor-widget elementor-widget-text-editor\" data-id=\"3dc6bf9\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ed41b49 elementor-widget elementor-widget-text-editor\" data-id=\"ed41b49\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>One of the first questions you may have when you\u2019re looking through the ISO 13485:2016 requirements is about the phrase \u201capplicable regulatory requirements.\u201d That phrase is used throughout the standard to require organizations to identify all of the global regulatory requirements that are relevant to their organization\u2019s quality system. But if FDA is following this requirement, does that mean they will be asking you about how you meet the quality system requirements for all the countries where you market your devices? Fortunately, no. FDA has made it clear in QMSR 820.10(b) that the \u201capplicable regulatory requirements\u201d for FDA will be only other US regulations (e.g., 21 CFR Part 803 for reporting to regulatory authorities).<\/p><p>\u00a0<br \/>Check out <a href=\"https:\/\/www.orielstat.com\/blog\/fda-qsr-vs-qmsr\/\">our previous QMSR blog<\/a> that walks through the big changes from the QSR to the QMSR:<br \/>\u00a0<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-91e0879 elementor-widget elementor-widget-text-editor\" data-id=\"91e0879\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Of course, first you should read the QMSR and become familiar with the new structure and content of 21 CFR Part 820. The entire Regulation has been replaced with a new structure in QMSR \u2013 it is not just a revision of the existing QSR with sections taken out or replaced.<\/p><p>You also need to make sure you understand the full requirements of ISO 13485:2016. Even though it is \u201csubstantially similar\u201d (in FDA\u2019s opinion), there are still details within the standard that are not included explicitly in the QSR today.<\/p><p>If you are new to ISO 13485:2016 and need a copy quickly, you can view the standard content online via the <a href=\"https:\/\/ibr.ansi.org\/Standards\">American National Standards Institute (ANSI) Incorporated by Reference (IBR) Portal<\/a>. However, this online version is a read-only format, and you must register on the site each time you wish to see the document \u2013 not very convenient for your day-to-day work. For longer-term use, you need to purchase the standard for your organization. Once you have the standard, read it through from beginning to end, including the introduction (Clause 0).<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><a href=\"https:\/\/www.federalregister.gov\/documents\/2022\/02\/23\/2022-03227\/medical-devices-quality-system-regulation-amendments\" target=\"_blank\" rel=\"nofollow noopener\">The new Quality Management System Regulation <\/a>(QMSR) \u2013 FDA\u2019s long-awaited update to the medical device quality system requirements in 21 CFR Part 820 \u2013 is just one year away from becoming effective. The two-year transition period ends on February 2, 2026, when the Agency will begin enforcing the QMSR requirements.<\/p><p>The major change coming for those organizations who fall within the scope of the Regulation is the \u201cincorporation by reference\u201d of the requirements of ISO 13485:2016 Medical devices\u2014Quality management systems\u2014Requirements for regulatory purposes. ISO 13485 was introduced in 1996, which happens to be the last time a major update to 21 CFR Part 820 (QSR) occurred. Since that time, ISO 13485 has been modified a few times, and the most recent version \u2013 ISO 13485:2016 \u2013 is very similar to FDA QSR. In fact, many people with knowledge of the QSR and ISO 13485:2016 talk about the two containing nearly the same requirements.<\/p><p>This incorporation of ISO 13485:2016 by reference in the QMSR makes the ISO 13485:2016 requirements the basis for quality system compliance for manufacturers of medical devices, in-vitro diagnostics, and combination products with a device constituent marketed in the US. This approach means that all companies required to comply with the QMSR will essentially be following ISO 13485:2016 \u2013 even if they are not certified to the standard by a third party.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Key Regulatory References for the FDA Medical Device Inspection Compliance Program IntroductionFDA has released the Inspection of Medical Device Manufacturers Compliance Program 7382.850, effective February 2, 2026, formally replacing the long-standing Quality System Inspection Technique (QSIT). That alone is a big deal. Combined with the rollout of the Quality Management System Regulation (QMSR), it signals [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":4739,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[14,4,72],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/key-regulatory-references-for-the-fda-medical-device-inspection-compliance-program\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"Key Regulatory References for the FDA Medical Device Inspection Compliance Program IntroductionFDA has released the Inspection of Medical Device Manufacturers Compliance Program 7382.850, effective February 2, 2026, formally replacing the long-standing Quality System Inspection Technique (QSIT). 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