VectorCAST for FDA and IEC 62304 Certification

A wide variety of medical devices incorporate embedded software. Some of these, such as X-ray scanners and heart rate, blood pressure and breathing monitors, are used for analyzing patients. Others, such as medication pumps, are used to treat patients. In both cases, health and safety depend on the medical software deployed being reliable, safe and bug-free.

The IEC 62304 standard is formulated to govern the requirements for medical software, describes the process that medical software development and must go through in order to be approved for use in Europe. The standard includes guidelines for testing any software components that are part of a medical device.

The FDA has rigorous software quality requirements, comprised of three FDA developer testing levels: unit, integration level and system level testing. Unit (module or component) level testing focuses on the early examination of sub-program functionality and ensures that functionality not visible at the system level is examined by testing. Unit testing ensures that quality software units are furnished for integration into the finished software product. Integration level testing focuses on the transfer of data and control across a program's internal and external interfaces. External interfaces are those with other software (including operating system software), system hardware, and the users and can be described as communications links. System level testing demonstrates that all specified functionality exists and that the software product is trustworthy. This testing verifies the as-built program's functionality and performance with respect to the requirements for the software product as exhibited on the specified operating platform(s).

The VectorCAST embedded software test platform supports the creation and management of test cases to prove that the low level software requirements have been tested and is also useful for a variety of robustness testing activities such as range and out of bounds testing. Additionally, the VectorCAST tools support the capture and reporting of structural code coverage at all levels recommended by IEC 62304.

This datasheet provides the following information:

  • What is IEC 62304?
  • What is VectorCAST for FDA and IEC 62304?
  • Proving Due Diligence for FDA Audits
  • VectorCAST Tool Qualification Deliverable Process