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ISO 13485 Training
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Medical Devices Packaging System Validation as per ISO 11607
Validation Activities as per ISO 14644 requirements
Testing activity as per ISO 10993-7
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
Packaging System Aging study as per ISO 11607 and following ASTM F1980
Validation Activities as per ISO 11135 requirements and AAMI TIR 15 Read more >>
