North American Science Associates Inc.(NAMSA ) services

Environmental monitoring is performed to meet the requirements of quality system regulation when such an environment can influence the pre-sterilization bioburden level or resistance on a medical device.

Packaging Validation and Shelf Life Testing are essential components of your sterility assurance program. These tests ensure that sterility is maintained when a device is sealed in a package until expiration. We can assist you with all the testing associated with materials qualification, equipment qualification and process qualification.

In the world of medical device design, expertise in biocompatibility, sterilization, and validation for regulatory submissions is a prized commodity. NAMSA’s Product Safety and Validation Services Group is home to thought-leading experts who provide strategic advice and support that saves time and money  — all with an eye on regulatory compliance.