Quality System Regulation (QSR)
Adherence to the FDA’s Quality System Regulation (QSR) is often the greatest challenge facing Medical Devices and Biotech manufacturers. The scope of QSR is large, and non-compliance is not an option. As a result, E & E Medicals and Consulting help companies to meet the needs of those responsible for compliance issues, 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.