Patient Monitor System

Sterling Medical Devices participated in the development of a patient monitor system with Moderate Level of Concern software in order to support a 510(K) submission.

Sterling performed document preparation, change control, problem resolution, and applicable tool validations. Each deliverable was individually designed, coded and unit tested with detailed design, source code, and build configuration. Sterling also provided project management and resources to ensure that the project was completed in a timely manner. Weekly, we assembled code metrics, test, and financial metrics for the client, thus making sure that they had a clear understanding of the project’s status.

Since some components of the patient monitor system were already coded, Sterling performed porting to QNX in addition to designing, coding, and unit testing. Software development was performed with the QNX Momentics 4.7 IDE with the associated GCC tool chain, QNX Neutrino software stacks/utilities, and QNX Photon GUI libraries. As per the client’s request, we were able to provide an experienced software architect as a lead, one that was well acquainted with QNX Neutrino, runtime environment, and embedded medical device software development.

Static analysis tools were used for all software development and made accessible to the client; the tools used were Enterprise Architect (Design documents), Parasoft (UMT and Static Analysis), Klocwork (Static Analysis), SVN (Source and Document control), and Bugzilla (Issue Tracking). The unit test scripts were designed and developed via a mechanism that supports automated unit regression testing, and the unit test execution was integrated into the nightly build process.

Sterling Medical Devices provided an IEC 62304:2006 compliant, ISO 13485 registered QMS and deliverables were later transferred to the client’s QMS.

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