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Software Verification and Validation

Information technology in medical equipment has developed rapidly, with the use of software for instrument control and signal processing increasing steadily. However, software failures have also been linked to adverse events in medical equipment. As a result, software validation has become a key focus for medical device authorities worldwide. In addition to requiring medical device manufacturers to adopt software development lifecycle technologies, authorities also mandate the recording of software verification activities as a basis for product approval. Currently, the United States, the European Union, and Taiwan's TFDA require the submission of a medical device software validation report as part of the pre-market application process. We can provide test reports for your medical device software in accordance with IEC 62304.

VTC helps customers meet the following needs:

• According to Standard IEC 62304 requirements, issue the test report.