Software can be an essential component of the medical device, whether it is designing a new product or improving the functionality of an existing one. When it comes to the software in medical devices, one seemingly minor change can have drastic implications for device function and clinical performance. reliance on software functionality and the regulatory need to make sure the software works as intended becomes increasingly important.

In the verification phase, a medical device developer is testing to see that the medical device software meets software specifications. Verification should occur throughout the medical device software development life cycle. This type of verification is conducted in the development phase of the product. Since my experience was in the software area. Whenever we came across a failed test, the first approach was to re create the scenario to do root cause analysis. In this we would check to see in which circumstance the particular test failed. Since, sometimes there could be a network issue or an incorrect values would have passed, therefore we would not consider to be a failed test. If it continues to fail then we would determine a need for code change. The code change request would require some paperwork especially if it is a change to an existing product.