According to HITN, the FDA is considering a “pre-check like system” of quality controls for developers—when it comes to medical device software updates—that is modeled after the Transportation Security Administration's expedited security screening ...
Using VectorCAST to Satisfy FDA Software Testing Requirements - This whitepaper shows how VectorCAST products help satisfy FDA software testing requirements. In summary this document details:How VectorCAST automates FDA software testing requirements, What are the FDA requirements for software testing tools, and How does VectorCAST provide tool validation and documentation
Understanding IEC 62304: Best Practices & Avoiding Mistakes - This video will enable you to quickly understand IEC 62304, the international standard for medical device software;
- Contrast IEC 62304 with CMMI and other safety-critical standards
- Understand the top five mistakes in applying IEC 62304 and how to avoid them
- Understand the top five Best Practices in successful IEC 62304 deployment