FDA and IEC 62304 Compliance

The VectorCAST Medical Device Software Compliance Kit for FDA and IEC 62304 includes all necessary documentation for validating embedded software components used on all classes of medical devices. The kit includes test procedures, plans, coverage and test case reports necessary to demonstrate due diligence with FDA and IEC 62304 software quality requirements.

Using the Medical Device Software Compliance Kit

VectorCAST provides tool validation in the form of qualification documents. The qualification documents consist of Tool Operational Requirements (TOR) and Tool Qualification Data (TQD). TOR describes requirements for VectorCAST tools and TQD, the associated tests and test results. Coverage and test case reports are exportable to regular HTML or text for easy integration into product documentation.

FDA and IEC 62304 Medical Device Compliance Kit Contents

  • Tool Operation Requirements (TOR)
  • Tool Qualification Data (TQD)
  • Test Cases, Procedures, and Results with supporting documentation