Product Testing through Third-Party Labs

Ensuring that your medical device meets regulatory safety and performance requirements is essential. We provide a comprehensive range of testing services, including biocompatibility, sterilization, endotoxin, and packaging integrity testing, all through accredited third-party labs.

• Biocompatibility Testing: Biocompatibility testing as per ISO 10993 to evaluate biological safety of devices (cytotoxicity, sensitization, irritation).
Standards: ISO 10993

• Sterility Testing: Validation of sterilization processes ensuring devices are free of viable microorganisms.
Standards: ISO 11737, ISO 11135

• Residual ETO Testing: Testing for residual ethylene oxide (ETO) ensuring no harmful residues remain.
Standards: ISO 10993-7

• Residual ECH & EG Testing: Testing for ethylene chlorohydrin (ECH) and ethylene glycol (EG) safety after sterilization.
Standards: ISO 10993-7

• Bacterial Endotoxin Testing (BET): Ensuring bacterial endotoxins are below limits.
Standards: ISO 10993-5, USP <85>

• Packaging Testing: Verifying durability and barrier properties of packaging.
Standards: ISO 11607

• Transport Study: Ensuring devices remain intact during transport.
Standards: ISO 11607

• Calibration & Validation: Facilitating calibration and validation of devices to comply with regulatory standards.