Dedicated to Quality Assurance
As an FDA 510(k)- cleared Class II medical device, the EXCELSIOR™ software is compliant with FDA requirements. EyeKor's Quality Assurance team continuously monitors and maintains onsite quality processes to ensure ongoing regulatory compliance.
- Quality Assurance operations headed by ASQ-certified staff
- Extensive experience with GxP, ISO, ICH, software validation, auditing, medical devices, pharmaceuticals, CAPA, process improvement, risk assessment, and quality management systems
- GxP compliance monitoring of ongoing activities in support of clinical and pre-clinical trial management
- GDPR Compliance Privacy Shield process in progress