Modern medical devices increasingly leverage microprocessors and embedded software, as well as sophisticated communications connections, for life-saving functionality. Insulin pumps, for example, rely on a battery, pump mechanism, microprocessor, sensors, and embedded software. Pacemakers and cardiac monitors also contain batteries, sensors, and software. Many devices also have Wi-Fi- or Bluetooth-based communications capabilities.
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