How Will This Affect Medical Device Manufacturers?
🔹 Companies already certified to ISO 13485: These manufacturers will likely experience minimal disruption but should still review their systems to ensure full compliance with FDA expectations.
🔹 Companies operating under QSR alone: Businesses that do not currently adhere to ISO 13485 will need to update their processes, quality procedures, and training programs to meet the new requirements.
🔹 FDA inspections: The agency’s audit process will transition to a more ISO 13485-aligned approach, meaning companies must prepare for potential shifts in compliance expectations and documentation review.
What Should Companies Do to Prepare?
📌 Conduct a Gap Analysis – Assess current QMS practices against ISO 13485:2016 to identify gaps and necessary adjustments.
📌 Train Teams and Update Processes – Ensure staff members understand the new QMSR requirements and update procedures accordingly.
📌 Enhance Supplier Management Systems – ISO 13485 places significant emphasis on supplier controls; companies should strengthen supplier qualification and oversight programs.
📌 Prepare for FDA Inspections – Understanding the new audit process is critical to ensuring compliance under QMSR.
📌 Seek Expert Guidance – Consulting with regulatory experts, such as OneGlobal Trinity M Consulting, can help streamline the transition and ensure full compliance with the new regulation.
Final Thoughts
The FDA’s adoption of QMSR marks a major milestone in harmonizing U.S. medical device regulations with global standards. While companies already following ISO 13485:2016 will see a smoother transition, those relying solely on FDA’s previous QSR must act now to align with the updated framework.
With the February 2, 2026 deadline approaching, proactive planning is key. If your organization needs assistance navigating this regulatory shift, OneGlobal Trinity M Consulting is here to help. Our experts specialize in quality and regulatory compliance, ensuring a seamless transition for your business.
📩 Contact TrinityMConsulting today to learn more about how we can support your compliance journey!
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