The FDA’s recent amendments to 21 CFR 820 have introduced significant changes to the Quality Management System Regulation (QMSR) for device manufacturing. These updates, effective from February 2, 2026, bring U.S. regulations in closer alignment with ISO 13485:2016.
The clock is ticking, the time to prepare is now. Our comprehensive whitepaper provides a step-by-step guide to ensure your organization is fully prepared to meet these new compliance requirements and avoid costly compliance pitfalls.
Why You Need to Act Now:
- Avoid Non-Compliance Penalties: The new QMSR requirements are comprehensive, and failing to comply by the deadline could result in severe penalties, product recalls, or even halts in production.
- Stay Competitive: Early adopters of the new regulations will not only ensure compliance but will also gain a competitive edge by demonstrating a commitment to quality and safety.
- Mitigate Risks: The new regulations emphasize risk management, traceability, and document control. Preparing now ensures your processes are robust and can withstand regulatory scrutiny.
- Seamless Transition: Transitioning to the new QMSR requirements is a complex process that requires time for proper planning, training, and system upgrades. Starting now allows you to manage these changes without disrupting your operations.
Key Benefits:
- Step-by-Step Guidance: Our whitepaper outlines the six critical steps you must take to achieve QMSR compliance, from establishing risk management processes to streamlining design controls.
- Expert Insights: Learn how to align your quality management system with the FDA’s new requirements while maintaining operational efficiency.
- Proactive Compliance: Equip your team with the knowledge and tools to meet the February 2026 deadline with confidence, ensuring continuous compliance and product safety.
Download the Whitepaper today and equip your team with the knowledge and tools to confidently navigate the FDA’s QMSR Final Rule. Don’t leave compliance to chance. Start preparing now to safeguard your operations, reputation, and bottom line.
