FDA QMSR and ISO 13485: Harmonisation Guide
Prepare Your Life Sciences Organisation for Regulatory Changes
The FDA's harmonisation 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) harmonisation 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
- Understand the key differences between 21 CFR Part 820 and ISO 13485, and how the harmonisation will affect your quality management system.
- Discover practical steps to prepare your organisation for the transition, including documentation updates and risk management processes.
- Learn about the potential challenges and opportunities presented by the FDA QMSR harmonisation, and how to leverage them for improved efficiency and global market access.
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Why QMSR Harmonisation Matters to Manufacturers
The FDA QMSR harmonisation 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 harmonisation 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 harmonisation facilitates a more cohesive global regulatory landscape, benefiting both manufacturers and patients worldwide.
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FAQ: FDA QMSR and ISO 13485 Harmonisation
How will the QMSR harmonisation affect UK and EU manufacturers?
The FDA QMSR harmonisation 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.
When will the QMSR harmonisation take effect?
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.
Will ISO 13485 certification be sufficient for FDA compliance?
While the QMSR harmonisation 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
How can we prepare for the QMSR harmonisation?
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.
Get Ready for QMSR Harmonisation
Prepare your life sciences manufacturing for FDA QMSR and ISO 13485 harmonisation with our comprehensive FAQ guide
Download the QMSR Harmonisation FAQMasterControl: Your QMSR Harmonisation Partner
Streamline your transition to the harmonised FDA QMSR and ISO 13485 standard with MasterControl's comprehensive solutions
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Document Control:
Easily manage and update your QMS documentation to meet new QMSR requirements.
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Risk Management:
Integrate risk-based approaches across your entire product life cycle for QMSR compliance.
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Training Management:
Ensure staff competency on new harmonised standards with automated training tracking.
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Audit Management:
Simplify internal audits and FDA inspections with our QMSR-aligned audit tools.
