Medical Device LIMS

Medical Devices are manufactured in a sterile environment that must be continuously monitored to detect changing trends in the manufacturing environment. Samples are pulled and tested on a routine basis (i.e. weekly, monthly, semi-annually, etc.). Data must be collected, and analyzed against environmental test limits, to ensure products that are released to market meet strict safety criteria, as well as being on time and to budget.

The Matrix Gemini LIMS highly configurable solutions meet these exacting needs, allowing laboratories to test conditions and to log the results with a complete audit trail to meet regulatory requirements.

For Environmental Monitoring (EM) testing, the collected samples need to be associated with particular analysts, control samples, instrumentation and in/out of incubation dates. In addition, observational monitoring documentation can be associated with testing of a particular controlled environment. The user can optionally associate morphology data with the batch of collected samples.

For sterilization testing, the user typically records the sterilization method, cycle type and cycle number along with the tests to be performed on the device and their specifications. The testing is then approved and any out-of-specification documentation can be associated with a particular device along with various types of notes.