QARS SOLUTIONS EXPERTS: FDA REGULATIONS & ISO STANDARDS

 

 

QARS SOLUTIONS EXPERTS IN MEDICAL DEVICE QMS ALIGNMENT

The FDA is aligning its Quality System Regulation (QSR) with ISO 13485:2016 through the new Quality Management System Regulation (QMSR), which will become effective on February 2, 2026. This alignment represents a significant change in medical device quality management regulations in the United States, bringing them closer to international standards while maintaining certain FDA-specific requirements.

ISO 13485 is an internationally recognized standard for creating a QMS for medical device companies anywhere in the world.

ISO 13485 specifies the requirements for a quality management system specifically designed for medical devices. This standard covers various aspects of the product life cycle, including design, development, production, installation, and servicing. By implementing this standard, organizations can enhance their processes and minimize risks associated with the manufacturing and distribution of medical devices.

While the QMSR aligns closely with ISO 13485, it is not identical. The FDA has included additional definitions and provisions to address potential inconsistencies and maintain certain FDA-specific requirements. 

QARS Solutions: Your Partner in Quality Excellence

Let QARS Solutions be your contract quality organization (CQO) to manage and complete this program, so you can focus on delivering high-quality products to your customers.