S
Dear all,
My company has been developing piece of firmware that was initially classified as Class A and then upgraded to Class B based on risk come out later on. Since class A software does not require Unit level testing, the test results were not documented. The project has been going on for over 2 years and now is fully integrated. Per IEC62304 class B requirements, unit level testing has to be performed and documented. What are my options now? It is almost not possible to go back to all the units to perform testing...thanks!
My company has been developing piece of firmware that was initially classified as Class A and then upgraded to Class B based on risk come out later on. Since class A software does not require Unit level testing, the test results were not documented. The project has been going on for over 2 years and now is fully integrated. Per IEC62304 class B requirements, unit level testing has to be performed and documented. What are my options now? It is almost not possible to go back to all the units to perform testing...thanks!