Used in the medical device industry, the IEC 62304 standard provides a framework for software lifecycle processes with activities and tasks necessary for the safe design and maintenance of medical device software. The US FDA accepts IEC 62304 compliance as evidence that medical device software has been designed according to the required regulations/standards, as it enforces traceability and repeatability of the development and maintenance process.
Enforcing IEC 62304 Compliance with Source Code Analysis, Unit Testing, Traceability, and More
The IEC 62304 standard introduces different measures to assure proper software design, implementation, and testing depending on the possible effects of the software failure on the patient. Parasoft users can leverage Parasoft C/C++test to reduce the cost of achieving IEC 62304 compliance by automating multiple testing methods required by the standard to save time and effort.