CSSi LifeSciences, a leading partner in the life sciences industry, is pleased to announce its full support and commitment to the U.S. Food and Drug Administration’s (FDA) newly issued Quality Management System Regulation (QMSR) Final Rule. This significant regulatory update emphasizes the importance of risk management and harmonizes domestic and international quality standards for medical devices, ensuring they remain safe, effective, and of the highest quality for patients worldwide. By aligning more closely with international standards, the FDA aims to facilitate global market access for medical devices while maintaining strict safety and efficacy standards.
Jim Sergi, President at CSSi LifeSciences, stated, “We welcome the FDA’s QMSR Final Rule as a significant step forward in the global harmonization of medical device regulation. This alignment not only supports our commitment to delivering high-caliber Quality Management Systems to our clients but also enhances the operational efficiency of our clients’ global operations and facilitates the US market entry of our international clients.”
CSSi LifeSciences is dedicated to ensuring that the Quality System we offer to our clients meets the highest industry standards. In response to the FDA’s final rule, we are proactively reviewing and updating our quality management system to fully comply with the new QMSR requirements well ahead of the February 2, 2026 compliance deadline.
“We are committed to working closely with our clients to assist with implementing these harmonized Quality System changes, to ensure that the medical devices brought to market continue to meet the rigorous safety and quality standards expected by healthcare providers and patients,” added Janice Cattano, Senior VP of Medical Devices and Clinical Operations.
The QMSR Final Rule is a testament to the FDA’s ongoing efforts to promote global harmonization in medical device regulation. CSSi LifeSciences is proud to be at the forefront of adopting these enhancements, furthering our mission to advance healthcare innovation and improve patient outcomes worldwide.
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About CSSi LifeSciences
CSSi LifeSciences is a global, innovative CRO and consulting group. We specialize in advancing therapeutics and medical devices through development and regulatory approval. We offer customized solutions that mitigate risk, time, and expense to support the U.S. market goals of your company.