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What happens when FDA QSR harmonizes with ISO 13485?

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Mar 07, 2024

samd series | author

Weronika Michaluk

Digital Health Principal
SaMD Lead at HTD Health

On February 23, 2022, the FDA announced its proposal for the new Quality Management System Regulation (QMSR), a significant change in regulatory harmonization. This proposed QMSR is set to merge the current good manufacturing practice (cGMP) stipulations of the FDA’s Quality System Regulation (FDA QSR) with ISO 13485:2016, the international standard for medical device quality management systems.

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FDA finally announces harmonization

In the world of medical devices, having a strong quality management system (QMS) is key to making sure products are safe and work well. For a long time, companies making these devices had to follow the FDA’s Quality System Regulation (FDA QSR) in the U.S., or follow regulations set by the international standard ISO 13485.

This announcement has created excitement within the medical device sector, marking a big moment in the long-anticipated harmonization of the FDA’s QSR and ISO 13485 standards. Since 2018, stakeholders in the medical device industry have been waiting for this alignment, and the FDA’s recent move has turned this anticipation into reality.

Furthermore, the FDA has indicated a grace period of at least one year from the finalization of the rule to its official implementation. This timeline suggests that the earliest the QMSR could be enacted is by December 2024, providing medical device manufacturers time to adapt to the coming changes.

To delve deeper: the FDA’s decision to harmonize its QSR with ISO 13485 comes from a desire to streamline regulatory requirements, enhance the global competitiveness of U.S. medical device manufacturers, and, most importantly, ensure the delivery of safe and effective medical devices to consumers. The integration of these standards into the new QMSR will necessitate adjustments within medical device companies, affecting how they implement and manage their quality management systems (medical device QSR)

Understanding ISO 13485

ISO 13485 represents a critical benchmark for quality management systems (QMS) within the medical device industry, providing an international framework that medical device manufacturers must adhere to.

This standard is important in assisting companies to establish, maintain, and enhance their QMS, ensuring that the lifecycle of medical devices—from design and production to distribution—meets the highest possible standards of quality and safety. As a globally recognized standard, ISO 13485 underscores the importance of aligning with international best practices, facilitating smoother global operations for medical device companies, and helping their products gain recognition and acceptance across various international markets. See also: How to Get ISO 13485 Certification? 10 Most Frequently Asked Questions

The essence of ISO 13485 is its comprehensive approach toward quality assurance in the medical device sector, emphasizing the critical need for a systematic and consistently applied QMS. This ensures that medical devices are not only designed and produced to meet specific quality and safety requirements but are also capable of satisfying customer and regulatory demands both domestically and internationally.

By adhering to ISO 13485, companies can demonstrate their commitment to quality and safety, which is crucial in the highly regulated medical device field. This standard serves as a foundation for meeting regulatory requirements in numerous countries, making it a key facilitator for accessing the global market.

The FDA QSR and ISO 13485 Harmonization: Implications for Medical Device Companies

The harmonization between the FDA QSR (Quality System Regulation) and ISO 13485 is a significant development with profound implications for companies involved in the medical device sector.

The FDA QSR, a regulation that is specifically tailored to the United States, establishes comprehensive guidelines for the quality management systems essential in the manufacturing and distribution of medical devices. This regulation emphasizes critical areas such as design control, the manufacturing process, and post-market surveillance to ensure that medical devices conform to the high standards required for the U.S. market. The primary objective of the FDA QSR is to enforce stringent quality control measures, guaranteeing that medical devices available in the U.S. adhere to the highest levels of quality and safety.

By aligning the US FDA QSR with ISO 13485, the FDA aims to streamline the regulatory requirements for medical device companies, facilitating a more integrated approach to quality management across global markets. This alignment underscores the importance of maintaining consistent quality standards in the design, production, and post-market evaluation of medical devices, enhancing their safety and efficacy. The harmonization effort is designed to reduce regulatory burdens and improve the efficiency of quality management practices, making it easier for medical device manufacturers to comply with both U.S. and international standards.

Moreover, this strategic alignment between the FDA QSR and ISO 13485 represents a commitment to global best practices in medical device quality management, encouraging a culture of continuous improvement and innovation within the industry.

By adopting a unified quality management system that meets both FDA QSR and ISO 13485 standards, medical device companies can better position themselves in the global market, ensuring their products are competitive and compliant with regulatory requirements across different regions. This harmonization is poised to elevate the standard of medical devices by ensuring they are produced under rigorous quality controls, thereby enhancing patient safety and satisfaction with medical devices marketed in the U.S. and beyond.

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Key Differences between ISO 13485 and the FDA QSR

While both ISO 13485 and the FDA QSR share the common goal of ensuring the quality of medical devices, there are some key differences between the two standards.

  1. Scope and Application: ISO 13485 has a broader scope, encompassing all stages of the product lifecycle, from design and development to manufacturing and post-market surveillance. The FDA QSR, on the other hand, focuses primarily on the manufacturing and distribution processes.
  2. Regulatory Language: ISO 13485 is written in general terms, providing a flexible framework for companies to adapt to their specific needs. The FDA QSR, as a regulatory document, is more prescriptive, outlining specific requirements and expectations.
  3. Certification Options: ISO 13485 certification is voluntary, while FDA QSR compliance is mandatory for all medical devices marketed in the US. Companies can seek ISO 13485 certification to demonstrate their commitment to quality and gain recognition in the global market.

Understanding the Implications for Medical Device Manufacturers

The anticipated harmonization of the FDA’s Quality System Regulation (FDA QSR) with ISO 13485 seeks to align the US FDA QSR standards with the globally recognized ISO 13485 standards, is expected to reshape the regulatory and operational landscape for medical device companies significantly. Here are some expanded key implications of this harmonization:

Firstly, the alignment of the FDA QSR with ISO 13485 will likely result in streamlined regulatory compliance for medical device manufacturers. By reducing the complexity and duplicity of adhering to two distinct sets of standards, companies can focus on a singular, unified QMS framework. This simplification will facilitate a more efficient path to compliance, enabling companies to allocate resources more effectively, reduce compliance-related overheads, and accelerate the time-to-market for new and innovative medical devices.

Additionally, this harmonization effort is set to enhance the global competitiveness of US-based medical device manufacturers. With the US FDA QSR and ISO 13485 operating under a common framework, medical device companies will find it easier to navigate international markets, as their compliance with the harmonized standard will be recognized globally. This could lead to expanded market access, opening doors to new opportunities and collaborations worldwide, further driving growth and innovation in the sector.

Moreover, the harmonization of the FDA QSR and ISO 13485 standards is expected to elevate the overall quality and safety of medical devices. By adhering to a comprehensive set of practices that encompass both the requirements of the US market and the international standard set by ISO 13485, manufacturers will be better positioned to ensure the highest standards of product quality and patient safety. This not only benefits end-users but also enhances the reputation and trustworthiness of manufacturers in the highly competitive medical device industry.

Lastly, the harmonization initiative is likely to foster a culture of continuous improvement among medical device manufacturers. With a harmonized QMS that emphasizes efficiency, quality, and innovation, companies will be encouraged to constantly evaluate and enhance their processes, products, and services. This continual pursuit of excellence will drive advancements in medical technology, leading to better healthcare outcomes and contributing to the overall well-being of communities around the world.

How to prepare to FDA QSR Harmonization?

As the FDA moves closer to finalizing the integration of the US FDA QSR with ISO 13485, and creating a harmonized Quality System Regulation for medical device companies, proactive preparation is essential for a seamless adaptation to the new requirements. This preparatory phase is crucial for companies to ensure their Quality Management Systems (QMS) are fully compliant with the upcoming harmonized medical device QSR standards.

Firstly, companies must conduct an in-depth review of their existing QMS frameworks. This involves a detailed assessment to pinpoint any discrepancies or areas of improvement that need to be addressed to comply with the harmonized FDA QSR guidelines. Identifying these gaps early on will allow companies to make necessary adjustments in alignment with the combined US FDA QSR and ISO 13485 standards, ensuring their medical device QSR processes meet both current and future regulatory expectations.

Furthermore, seeking expert guidance is a pivotal step in navigating the complexities of the harmonized QSR. Engaging with knowledgeable consultants or auditors who specialize in FDA QSR and medical device QSR compliance can provide invaluable insights. These experts can offer tailored advice and help create a comprehensive compliance strategy that covers all aspects of the harmonized regulations, from design controls and manufacturing processes to post-market surveillance and quality assurance.

Staying informed is another critical aspect of the preparation process. Companies should make it a priority to keep abreast of the latest updates and guidance from the FDA regarding the harmonized QSR. Leveraging FDA guidance documents, attending relevant workshops and seminars, and subscribing to industry publications are effective ways to stay informed. This continuous learning approach will ensure that companies are not only aware of the current regulatory landscape but are also well-prepared to implement the harmonized QSR once it is officially enacted. That’s why we also invite you to subscribe to our newsletter to stay up to date with all SaMD-related topics.


Harmonization of the QSR with ISO 13485 is a significant step forward for the medical device industry, promising to streamline compliance, enhance efficiency, and facilitate global market access. By proactively preparing for the harmonized QMS, medical device manufacturers can capitalize on these opportunities and focus on delivering innovative and high-quality products that meet the needs of patients worldwide.

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