Medical Engineering: PLM Ensuring Compliance
Companies involved in the field of medical technology not only have to provide evidence of the reliability of their products; the regulatory authorities also check that they exercised due diligence during development and production. Olympus Surgical Technologies Europe relies on PLM to cope with the ever increasing compliance requirements.
As a global manufacturer of medical equipment, Olympus Surgical has to meet the requirements of different markets and regulatory authorities. Alongside the regulations from the US Food & Drug Administration (FDA) and the European Medical Device Directive (MDD), new standards are emerging from developing economies such as China, as they develop and enforce their own regulations. The net result is that an increasing number of documents have to be provided.
Whereas documentation of aspects relating to the product itself is the main focus of the approval process, regular audits also have to be performed, in which it must be demonstrated that the development and manufacturing processes are designed in such a way that they cannot impair the safety of the product. In this context, PLM support is a great help to Olympus Surgical, particularly as different divisions at different locations collaborate in the product development process.
The medical equipment manufacturer replaced an existing CAD data management system with CIM Database to allow them to integrate management of the documentation needed for approval and audits within a homogeneous system environment. Documents and CAD data are now systematically assigned to article master data so that processes such as release and change management can be designed reliably. The fact that document management is integrated in the PLM system delivers considerable time and cost savings in day-to-day project work. During the next phase, Olympus Surgical intends to extend the PLM platform to provide a tool for managing development projects and enhance portfolio management.
PLM IT Report No.1, February/March 2014