TECHNICAL SUPPORT

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Technical Support

Your strategic partner in design control, Pre-clinical safety and sterilization .

Design control

Change management
Input/Output traceability
Project management (Class I, II, III devices & Drug/device combinations)
Stability validations (Accelerated, Real-time)

Biocompatibility and E&L (ISO 10993-xx, USP 1031)

Biological Evaluation Plan (BEP)
Biological Evaluation Report (BER)
Chemical & drug/device compatibility

Sterility, Biological safety

Sterilization validations (Moist heat, EtO, Gamma), IQ-OQ-PQ.
Microbial ingress
Microbiological audit support