Prepare Your Life Sciences Organization for Regulatory Changes
The FDA's harmonization of 21 CFR Part 820 with ISO 13485 marks a significant shift in medical device quality management. This comprehensive guide offers UK and EU life sciences manufacturers essential insights into the Quality Management System Regulation (QMSR) harmonization process, its impact on current practices, and strategies for ensuring compliance. Stay ahead of the curve and streamline your quality management processes with our expert analysis and practical recommendations
The FDA QMSR harmonization with ISO 13485 represents a pivotal shift for life sciences manufacturers. This alignment streamlines regulatory compliance, reducing the burden of adhering to multiple standards. For UK and EU manufacturers, understanding the QMSR harmonization is crucial for maintaining access to the U.S. market. It offers the potential for cost savings, improved efficiency, and enhanced global competitiveness. By adopting a unified approach to quality management, manufacturers can streamline their processes, reduce redundancies, and focus on innovation. Ultimately, this harmonization facilitates a more cohesive global regulatory landscape, benefiting both manufacturers and patients worldwide.
The FDA QMSR harmonization with ISO 13485 will streamline compliance for UK and EU manufacturers seeking access to the U.S. market. It reduces regulatory burden by aligning quality management requirements many are already adhering to, potentially simplifying audits and inspections.
The FDA published the final rule in January 2024, which provides a two-year transition period. Manufacturers should prepare to be fully compliant with the new requirements by early 2026.
While the QMSR harmonization aligns closely with ISO 13485, certification alone won't guarantee FDA compliance. Manufacturers will still need to meet specific FDA requirements and be subject to FDA inspections
To prepare, review your current quality management system against ISO 13485:2016 and the new QMSR requirements. Update your documentation, train staff on the changes, and consider implementing a digital QMS to streamline compliance efforts.
Prepare your life sciences manufacturing for FDA QMSR and ISO 13485 harmonization with our comprehensive FAQ guide
Download the QMSR Harmonization FAQStreamline your transition to the harmonized FDA QMSR and ISO 13485 standard with MasterControl's comprehensive solutions
Easily manage and update your QMS documentation to meet new QMSR requirements.
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Ensure staff competency on new harmonized standards with automated training tracking.
Simplify internal audits and FDA inspections with our QMSR-aligned audit tools.