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MEDICAL DEVICE

Medical device companies need strong technical support in their quest to bring safe and effective products to patients and their doctors. PBL provides a broad array of services to support device development and manufacturing—from materials selection and device design through manufacturing and lot release.

Categories of Medical Device Testing

Biocompatibility Testing procedures help device engineers screen materials for safety characteristics. Finished product testing per ISO 10993 provides documentation of device safety for regulatory approvals.

USP Class Plastics Tests are sometimes performed on materials, but medical devices require a more rigorous, full suite of biocompatibility testing.

Sterilization Validation is required to assure the efficacy of sterilization cycles, whether gamma, e-beam, ethylene oxide or steam. Where dosimetric or parametric release is not practical, lot release sterility testing may be necessary to demonstrate that safety requirements have been met.

Sterility Tests include bioburden, microbial identification, dose audits, testing for sterility, as well as endotoxins (LAL) tests. In addition, reusable medical devices may require cleaning and disinfection validations.