Using Dynamic Software Analysis to Support Medical Device Approval

Demonstrating dependability

To ensure that their devices receive regulatory agency approvals, manufacturers must demonstrate that the devices meet their safety specifications. For the device software, this means demonstrating that the ...

IEC 62304

IEC 62304 is becoming the de facto global standard for medical device software life cycle processes. The FDA has driven its development, and it is being harmonized with EU standard 93/42 EWG (MDD). Like the other standards shown in Figure ...

Dynamic analysis

Dynamic analysis is used to examine execution of the compiled source code, either in its entirety or on a piecemeal basis. Since dynamic analysis executes code, it tests not only the source code, but also the compiler, the linker, the development ...

Choosing a software analysis tool

All software tool vendors are keen to sell their wares and, understandably, few vendors are particularly keen on advertising what their tools might not do. The following are a list of key points to consider when evaluating a software analysis tool. ...

Conclusion

With complex software systems at the heart of so many medical devices, the success of these devices is increasingly dependent on the manufacturer’s ability to demonstrate that these systems meet required levels of dependability. While ...

Appendix A: IEC 62304 and development activities

The tables in this section map paragraphs in IEC 62304 with software design, development and validation activities. Adherence to IEC 62304 doesn’t guarantee that the software will meet sufficient dependability requirements or that agency ...

Appendix B: the operating system

No matter how good the validation tools, ultimately it is the device and its software that must receive approval. In any system that uses software, everything above the silicon depends on the OS. This means that any medical device that includes a ...