Understanding the Changes: Familiarize Yourself with the Updated FDA QSR and its Alignment with ISO 13485

The United States Food and Drug Administration (US FDA) released the highly anticipated revised Quality Management System Regulation (QMSR) in February 2024. The updated regulation serves as the new set of Good Manufacturing Practices (GMP) guidelines of the US FDA for medical devices, effectively replacing the previous set of Quality System Regulations (QSR). The US FDA QMSR now aligns more closely with the ISO 13485:2016, the international standard for medical device Quality Management System (QMS).

One of the key benefits of the US FDA QMSR is its ability to reduce the burden of documentation on the medical device industry. Medical device manufacturers and importers will have a two (02)-year transition period, until February 2026, to align their operations with the new QMSR requirements.

A Few Key Details on QMSR Requirements

The US FDA has revised certain definitions in the current QMSR to align it with ISO 13485. This includes terms/phrases such as “management with executive responsibility,” “Device Master Record (DMR),” and “customer”. Some definitions that are unique to the US FDA will be retained, such as definitions of terms like “manufacturer,” “product,” and “device”. Harmonizing definitions will help create consistency and eliminate confusion. Here are two (02) key aspects of the updated QMSR:

• Risk Management: Aligned with ISO 13485 requirements, which are defined as per ISO 14971
  ISO 13485:2016, which outlines the requirements of a QMS for medical devices and references risk management in several clauses. While ISO 13485 itself does not provide detailed risk management procedures, it requires the application of a risk-based approach to control processes within the QMS.
• ISO 14971:2019: This standard is specifically dedicated to the application of risk management for medical devices. It provides a framework for manufacturers to identify hazards associated with their medical devices, estimate and evaluate the associated risks, implement appropriate risk controls, and monitor the effectiveness of these controls throughout the lifecycle of a device.
  Thus, while ISO 13485 requires a risk-based approach and includes elements related to risk management, the specific processes and activities for managing risks associated with medical devices are detailed in ISO 14971. It is recommended that manufacturers use ISO 14971 to establish and maintain a risk management system that meets the expectations of ISO 13485.

Management Responsibilities as Per ISO 13485

The management of an organization has some critical responsibilities to ensure that the QMS is effective and is able to achieve its intended outcomes. These management responsibilities are:

• Management Commitment: The top management of an organization must demonstrate their commitment to the development and implementation of QMS and continually improve its effectiveness. This includes communicating the importance of meeting customers’ and Regulatory requirements.
• Focus on Customers: The top management must ensure that customers’ requirements are determined, understood, and consistently met, as the ultimate aim is to enhance customer satisfaction.
• Quality Policy: The top management must establish a quality policy that is appropriate to the purpose of the organization, includes a commitment to comply with requirements and maintain the effectiveness of the QMS, and provides a framework for setting quality objectives.
• Planning: The management must ensure that the quality objectives are established at relevant functions and levels within the organization. They must also do proper planning to meet these objectives and maintain the QMS.
• Responsibility, Authority, and Communication: The management must ensure that all the responsibilities and authorities across the organization are defined and communicated. They must also appoint a management representative who will oversee the QMS and report on its performance.
• Management Review: The top management must review the organization’s QMS at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. This review should include an assessment of opportunities for improvement and the need for changes to the QMS; it must also include an examination of the organization’s quality policy and quality objectives.

Additional Documentation Requirements in the Updated QMSR

To ensure a balance between QMSR and 21 Code of Federal Regulations (CFR) Part 4 for combination products, additional documentation requirements have been introduced. They help in the harmonization of quality management practices with Regulatory standards, in turn, ensuring compliance across both frameworks. The requirements include:

• The US FDA’s Current Good Manufacturing Practice (cGMP) Compliance: Manufacturers of combination products must adhere to the cGMP requirements, as outlined in 21 CFR Part 4.
• QMSR: Manufacturers should ensure that their QMS complies with the US FDA’s regulations, including those specific to combination products.
• Stability Considerations: Stability testing and considerations are crucial for ensuring the safety and efficacy of combination products.
• Final Rule Compliance: Manufacturers must comply with the final rules on cGMP requirements for combination products issued by the US FDA.
• Understanding QMS Requirements: Manufacturers should understand QMS requirements specific to combination products, as outlined in 21 CFR Part 4.
• Clarification of CGMP Requirements: Manufacturers must understand and clarify the application of CGMP requirements to combination products, as per 21 CFR Part 4.

To sum up, it is important for medical device manufacturers to stay up to date with the current QMSR standards to seamlessly navigate through the Regulatory intricacies of the medical device market. Unlock quality excellence with Freyr Solutions! Elevate your QMS in accordance with the latest QMSR guidelines to ensure product safety, Regulatory compliance, and seamless partnerships. Our team of experts can help you at every step of your QMSR journey! Click here to book a meeting with us today.