QUALITY SYSTEM REGULATION (QSR)

Adherence to the FDA's Quality System Regulation (QSR) is often the greatest challenge facing Medical Device and Biotech manufacturers. The scope of QSR is large, and non-compliance is not an option. As a result, E & E Medicals, Inc helps companies to meet the needs of those responsible for compliance, regulatory affairs, project planning, design and development, technology transfer, R&D, QA and manufacturing in a QSR environment. Our clients have gained a comprehensive understanding of all components of the Quality System Regulation from Design Controls to Process Validation and Corrective and Preventative Action Plans (CAPA), document control systems, Process and design validation and risk management.

 

To learn more about quality system regulation contact us today