Teams at EKF Diagnostics Inc

Support regulatory compliance for medical devices/IVDs by preparing and maintaining registrations and submissions (e.g., 510(k)), managing UDI and documentation, assisting with adverse event reporting, coordinating with cross-functional teams, and ensuring adherence to standards (ISO, QMS, cGMP) and country-specific requirements.

Support and maintain the Quality Management System (QMS) for medical devices/IVDs: manage CAPAs, internal/external audits, document control, training, supplier qualification, batch release, risk management, trend analysis, and audit support to ensure regulatory compliance and inspection readiness.

Support day-to-day quality operations: batch record review and release, QC and environmental testing, instrument calibration, CAPA/NCR documentation, validation and document control support, data trending, audits, and ensure cGMP/QMS compliance in a manufacturing laboratory environment.