We empower our clients to connect the dots by helping them find solutions that directly fit the regulatory compliance needs of their business. With offices in the United States, United Kingdom, and Switzerland, our large global footprint allows us to meet the regulatory and quality support needs of international clients of all sizes. As a service-based organization, we are focused on delivering repeatable and sustainable success for our clients by embracing our core values and demonstrating our guiding principles on a daily basis.

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.