Understanding FDA's QSR Transition to ISO 13485: Implications for Medical Device Companies

The FDA’s transition from the Quality System Regulation (QSR) to ISO 13485 marks a significant shift in medical device regulatory compliance, aligning U.S. quality management requirements with global standards.

This change aims to harmonize regulations, reduce compliance burdens for manufacturers operating in multiple markets, and enhance product quality and patient safety. While QSR has long been the foundation for FDA-regulated medical device manufacturing, ISO 13485 introduces a more risk-based approach, stronger supplier control requirements, and increased emphasis on post-market surveillance. Understanding the key differences between these frameworks and the implications of this transition is crucial for medical device companies to maintain compliance and ensure smooth regulatory inspections.

This webinar will provide a comprehensive overview of the FDA’s adoption of ISO 13485, exploring the rationale behind the shift, key structural and procedural differences, and the impact on existing quality management systems. Participants will gain insights into compliance timelines, expected regulatory changes, and practical strategies for transitioning seamlessly. Whether you are a regulatory professional, quality manager, or medical device manufacturer, this session will equip you with the knowledge and tools needed to navigate the evolving regulatory landscape and implement ISO 13485 effectively within your organization.

Why You Should Attend:
Attending this webinar is essential for medical device professionals who need to stay ahead of regulatory changes and ensure their organizations remain compliant with evolving FDA requirements. With the FDA transitioning from QSR to ISO 13485, companies must understand the key differences, compliance expectations, and practical steps for a smooth transition.

This session will provide clear insights into the impact on quality management systems, supplier controls, risk management, and post-market surveillance-all critical areas for maintaining regulatory approval and market access. Whether you're a quality manager, regulatory affairs professional, or manufacturer, this webinar will equip you with actionable strategies to align with ISO 13485, prepare for audits, and mitigate compliance risks, ensuring your organization is well-positioned for success in this new regulatory landscape.

Areas Covered in the Session:

• Introduction
• Welcome and speaker introduction
• Objectives of the webinar
• Importance of understanding FDA's transition from QSR to ISO 13485
• Background and Rationale for the Transition
• Overview of the FDA’s Quality System Regulation (QSR)
• Introduction to ISO 13485:2016 and its global significance
• FDA’s reasoning for aligning with ISO 13485
• Expected benefits and regulatory harmonization efforts
• Key Differences Between QSR and ISO 13485
• Structural and Terminology Changes
• Quality management principles comparison
• Risk-based approach emphasis in ISO 13485
• Documentation and Recordkeeping Requirements
• Differences in quality documentation and controls
• Medical Device File (MDF) vs. Device Master Record (DMR)
• Supplier Management & Purchasing Controls
• Expanded supplier control requirements in ISO 13485
• Risk Management Integration
• ISO 14971 compliance expectations
• Post-Market Surveillance & Feedback Systems
• Expanded requirements in ISO 13485
• Other Key Differences
• Training, validation, and CAPA process adjustments
• Regulatory and Compliance Implications
• FDA enforcement and inspection expectations post-transition
• Compliance timelines and transition period
• Impact on current QMS for medical device manufacturers
• Potential challenges companies may face during transition
• Role of Notified Bodies and global regulatory alignment
• Strategies for a Smooth Transition
• Conducting a gap analysis between QSR and ISO 13485
• Updating quality management systems and documentation
• Staff training and organizational readiness
• Best practices for supplier and risk management adjustments
• Leveraging internal audits to ensure compliance
• Q&A and Closing Remarks
• Addressing participant questions
• Summary of key takeaways
• Additional resources for compliance
• Final thoughts and next steps

• Regulatory Affairs
• Quality Assurance & Compliance
• Medical Device Manufacturing
• Supplier & Vendor Management
• Risk Management
• Product Development & Engineering
• Operations & Production Management
• Internal & External Auditors
• Clinical & Post-Market Surveillance Teams
• Training & Organizational Development