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

Biocompatibility Testing Services

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

Ethylene Oxide (EO) Sterilization Validation

Validation Activities as per ISO 11135 requirements and AAMI TIR 15 Read more >>

Packaging Accelerated Aging Studies

Packaging System Aging study as per ISO 11607 and following ASTM F1980