The development of virtual testing resource for medical devices in Hsin-Chu biomedical science park

There are many key elements in the critical path for a novel medical device to reach market successfully. Total quality control of device life cycle has been identified as a working model by many authority bodies. We adapt this concept in the plan and implementation of a national project for a biomedical science park which will emphasize the linkages between academic researches, clinical trial, and industrial developments in Hsin-Chiu, Taiwan. In this ambitious project, we have identified several critical needs for the infrastructure supports. A virtual testing resource for the necessary verification and validation processes has been on the priority list for jointed efforts of several national organizations, especially for the traceability of medical standards in the quality system. According to our preliminary survey, there are 168 GMP/cGMP ertified institutions for the safety, stability and physical chemical tests of drugs and 1124 certified testing laboratories in Taiwan, which can support this virtual testing effort. With this background information, we have now identified six novel medical devices to test run the virtual resource in Taiwan. We are now in the processes to establish an edocument system to be part of the knowledge management system and be a part of the critical path for global services. We are also working on e-learning system for regulatory affairs in medical device.