Eagle Medical provides comprehensive validation services that are crucial for medical device path to market success. Our extensive experience with packaging, sterilization, and manufacturing validations ensures regulatory compliance and operational excellence.
Validation Capabilities
Sterilization validation for all modalities (EtO, HPGP, Gamma, E-beam)
Packaging validation including integrity testing and shelf-life studies
Process validation for manufacturing operations
Cleaning validation for reusable devices
Statistical process control implementation and monitoring
Documentation and Compliance
Protocol development following industry standards
Comprehensive reporting for regulatory submissions
Change control and revalidation management
FDA 510(k) and international submission support
Expert Guidance
Our team guides you through complex validation requirements with confidence, clarity, and efficiency, leveraging our vast library of materials and proven methodologies.
