Package validation

Medical Devices Packaging System Validation as per ISO 11607

Clean room validation

Validation Activities as per ISO 14644 requirements

Residual EO/ECH Analysis

Testing activity as per ISO 10993-7

Ethylene Oxide (EO) Sterilization Validation

Testing against the following standards 

Hemocompatibility testing ISO 10993-4

Cytotoxicity testing ISO 10993-5

Intracutaneous irritation testing ISO 10993-10

Sensitization testing ISO 10993-10

Systemic toxicity testing ISO 10993-11