EyeKor
An Imaging Company for Ophthalmic Clinical Trials
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Quality Assurance

Quality Assurance

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.

Expertise:

  • 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