In regulated industries, we take risk seriously—patient safety, product quality, and compliance are non-negotiable. But there’s a growing challenge inside many organizations that quietly threatens progress:…
December 2
The FDA’s transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) marks a significant shift for the medical device industry. This change aligns U.S. regulations with the international standard, ISO 13485. For medical device developers, understanding how to navigate this transition is essential for a smooth and successful path to market.
This new framework can feel complex, but it doesn’t have to be a roadblock. At MedLaunch, we simplify these regulations into clear, manageable steps. This guide will walk you through the key aspects of QMSR and explain how to prepare your systems for compliance with confidence.
What are the key differences between the old QSR and the new QMSR?
The biggest change is the FDA’s decision to incorporate ISO 13485:2016 by reference. The old QSR (also known as 21 CFR Part 820) had its own unique structure and requirements. The new QMSR harmonizes the U.S. system with the one used by most other regulatory bodies around the world.
While the core principles of ensuring device safety and effectiveness remain the same, the QMSR places a stronger emphasis on a risk-based approach throughout the entire product lifecycle, as defined in ISO 13485. The FDA has stated that the requirements of the old QSR and the new QMSR are substantially similar, but companies must now align their processes and documentation with the structure of ISO 13485. This is good news for companies already certified to ISO 13485 for international markets, as much of their existing system will meet the new requirements.
How can companies with existing systems ensure compliance?
If your company already has a Quality Management System (QMS) compliant with the old QSR or ISO 13485, you have a strong head start. You don’t need to build a new system from scratch. The key is to perform a gap analysis to identify where your current processes meet the new requirements and where updates are needed.
For companies already compliant with ISO 13485, the main task will be to address the specific additions and clarifications the FDA included in the final QMSR rule. For those accustomed to the old QSR, the focus will be on restructuring documentation and processes to align with the ISO 13485 framework. This includes updating procedures for risk management, design controls, and supplier management to reflect the international standard’s structure.
A Clear Path to QMSR Compliance with MedLaunch
Navigating the transition to QMSR can seem daunting, but MedLaunch provides the expert guidance to make it a straightforward process. We offer tailored consultation services to help you every step of the way. Our process includes:
- Gap Analysis: We assess your current QMS against the new QMSR requirements to create a clear, actionable plan.
- Strategic Implementation: Our team helps you update procedures, optimize documentation, and align your system with the ISO 13485 framework efficiently.
- Team Training: We provide targeted training to ensure your team understands the new requirements and their role in maintaining compliance.
Don’t let regulatory changes slow down your innovation. Partner with MedLaunch to ensure a seamless transition to the new QMSR.
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Ready to simplify your path to compliance? Contact MedLaunch today for personalized guidance on implementing the QMSR for your medical device.
Tags: ISO 13468, QMSR, quality management system
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