Facing the environmental challenges associated with operating in a global economy, Luminex needed a solution that would enable them to capture and report material compositions for all of their products. Specifically, they needed to track and comply with EU RoHS, EU REACH, Conflict Minerals, and Luminex internal substances that are specifically restricted in medical devices. To achieve this, they needed to implement processes and procedures to allow collaboration with suppliers directly and through a compliance content provider.
Zero Wait-State deployed the Product Governance and Compliance (PG&C) module for Luminex’s Agile PLM system, and provided a comprehensive listing of PX automations and a compliance data import tool, named DocPort, to support the RFI interaction with suppliers, the downloading and importing of content provider data from Total Parts Plus, and full regulatory reporting capabilities.
Luminex can fulfill the reporting and disclosure requirements for a wide array of compliance standards, and can dramatically reduce its global footprint and exposure to regulatory risks. Internally, they are able to support the entire compliance solution using a very small group of employees.
Due to stringent regulatory requirements Intuitive needed help setting up streamlined workflows to move information between its Windchill and Agile PLM systems. Manual, disjointed processes caused delays releasing designs and inconsistent data entry for Item data.
With both Windchill and Agile experience in the medical device industry, Zero Wait-State helped Intuitive design holistically integrated processes that streamlined workflow between Windchill and Agile. DesignState now provides fully automatic, two-way integration between the CAD and PLM systems, and it produces better outcomes for meeting regulatory management requirements.
Data consistency between the CAD and PLM systems is improved: file formats, file names, attribution, traceability, etc. Product design release integration with Agile is more streamlined. Achieving consistent data with no burden on resources means regulatory compliance is achieved with no extra effort by staff.
Teleflex had deployed Engineering Collaboration a couple of years earlier, but adoption had been slow so the company has not been able to use the module efficiently and effectively. They were looking to utilize Engineering Collaboration to enhance business practices.
Zero Wait-State worked together with a Teleflex user to enable them to become an Engineering Collaboration superuser. Through this, the user was able to identify best procedures for various scenarios at the company. Teleflex was also able to document procedures for quick reference guides and SOPs.
Before ZWS started working with Teleflex, users did not have ownership of their Engineering Collaboration solution. With the help of ZWS, Teleflex was able to capture ownership of their solution which was in line with their goals of the solution. User adoption is vastly improved and the company is realizing the benefits it sought from its PLM system.