## [Stay QMSR Compliant with Freyr’s Regulatory Expertise](/medical-devices/stay-qmsr-compliant-with-freyrs-regulatory-expertise) # Stay QMSR Compliant with Freyr’s Regulatory Expertise Navigate the QMSR transition with ease. Freyr’s expert medical device consultants will guide you in aligning your Quality Management System (QMS) as per the latest FDA Regulation. ### Speak to a QMS Expert # Only 01/08/2025 17:30:00 #### remaining to meet the QMSR transition. Your compliance journey starts with Freyr! ## What exactly is the FDA’s new rule for QMSR? The FDA's new Quality Management System Regulation (QMSR) updates Quality System (QS) Regulation, aligning it with ISO 13485:2016, the global medical device quality management standard. This change aims to harmonize Regulations, ensuring timely access to safe, high-quality medical devices. The QMSR incorporates ISO 13485:2016 requirements while maintaining consistency with other FDA Regulations. Updates to part 4 (21 CFR part 4) clarify QMS expectations for combination products, without altering cGMP requirements. The enforcement begins on February 2, 2026, giving time to manufacturers adapt to the QMSR transition. [Contact us for a seamless QMSR transition](javascript:void(0)) ## Focus on the transition period! With enforcement beginning in 2026, delaying the transition could lead to significant penalties. The two-year window provided to manufacturers is an opportunity to align their Quality Management Systems (QMS) with the new QMSR requirements. The enforcement begins on February 2, 2026, giving time to manufacturers adapt to the QMSR transition. ##### Utilize the transition period effectively in 2 simple steps: ![Accelerate your 510 (k) Approval Process](<> "Accelerate your 510 (k) Approval Process") ##### Step 1:  Identify gaps, train teams, and begin updates ![Accelerate your 510 (k) Approval Process](<> "Accelerate your 510 (k) Approval Process") ##### Step 2:  Audit, finalize changes, and ace compliance! ### Our expert team ensures a seamless transition with a tailored 4-step strategy: - Comprehensive Gap Analysis to identify critical updates - End-to-End Risk Management aligned with the device lifecycle - Strengthened Design Controls & Post-Market Surveillance systems - Staff Training on QMSR requirements & ISO 13485:2016 standard requirements/implementation Stay ahead of the compliance curve [Schedule your Consultation Today!](javascript:void(0)) ## Celebrating Customers Success Medical Devices Registration and LR Support Global Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain. ![Regulatory Affairs](/sites/default/files/clients-speaks-logos/mdv-logo4.webp) ##### Arie Henkin VP - Quality and Regulatory, Australia -based, Leading SaMD Company Medical Devices Swiss Rep Services Japan and Switzerland I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again. ![Regulatory Affairs](/sites/default/files/clients-speaks-logos/mdv-logo3.webp) ##### Darren Mansell Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company Medical Devices Registration and AR Services Malaysia and Indonesia Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress. ![Regulatory Affairs](/sites/default/files/clients-speaks-logos/mdv-logo2.webp) ##### Robert Menadue Regulatory and Quality Assurance Manager, Australia-based, Medical Device Manufacturing and Distribution Company PreviousNext ## Frequently Asked Questions ## 1. Will ISO 13485 certification alone ensure compliance with QMSR? No, ISO 13485 certification aids compliance but does not exempt manufacturers from FDA inspections. Additional steps must be taken to meet QMSR-specific requirements. ## 2. How long does the QMSR transition process take? The duration depends on your organization’s current QMS maturity and resource availability. A gap analysis is a critical first step to estimate the timeline and plan accordingly. ## 3. Why is transitioning to QMSR compliance crucial? Transitioning to QMSR compliance ensures your QMS meets FDA requirements and international standards, which helps in reducing Regulatory risks, improving product quality, and improving patient safety. ## 4. When should I start the QMSR transition process? Immediate action is recommended to ensure a smooth transition before Regulatory deadlines. Starting early provides the necessary time for gap analysis, training, and execution. ## 5. What are the risks of not transitioning to QMSR compliance? Failing to transition to QMSR compliance can have serious business consequences, including: - Non-compliance during FDA inspections - Delays in product approvals - Increased Regulatory inquiry - Possible fines or recalls Transitioning proactively safeguards your business against these risks and ensures uninterrupted operations and compliance. [Speak to QMS Experts](javascript:void(0)) ## Why Partner with Freyr? - ![On-Time Submissions](<> "On-Time Submissions") ### Streamlined Regulatory Compliance Our QMSR experts guide your organization through a hassle-free transition to the FDA's QMSR, ensuring precision and efficiency - ![Proven Track Record](<> "Proven Track Record") ### Tailored Compliance Solutions for Your Business Receive customized strategies that align with your device type and lifecycle, enabling a seamless and successful QMSR transition - ![End-to-End Solutions](<> "End-to-End Solutions") ### Risk Mitigation We ensure your QMS documentation meets FDA requirements, minimizing compliance risks   [Speak to QMS Experts](javascript:void(0)) $(function() { countDown.init(); updateCountdowns(); setInterval(updateCountdowns, 1000); function updateCountdowns() { countDown.validElements.forEach((element, i) => { countDown.changeTime(element, countDown.endDate[i], i); }); } }); const countDown = { endDate: [], validElements: [], display: [], initialHeight: undefined, initialInnerDivMarginTop: undefined, originalBorderTopStyle: undefined, init: function() { $('.countDown').each(function() { const regex_match = $(this).text().match(/([0-9]{1,2})\/([0-9]{1,2})\/([0-9]{4}) ([0-9]{2}):([0-9]{2}):([0-9]{2})/); if (!regex_match) return; const end = new Date(regex_match[3], regex_match[2] - 1, regex_match[1], regex_match[4], regex_match[5], regex_match[6]); if (end > new Date()) { countDown.validElements.push($(this)); countDown.endDate.push(end); countDown.changeTime($(this), end, countDown.validElements.length - 1); $(this).html(countDown.display.next.map(item => `
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