I work for a medical device engineering company in MA and we are not that familiar with the IEC 62304 process. We are self-teaching; there are many good resources I have to draw on but, since Elsmar Cove bit the dust, I miss having an interactive forum to ask and answer questions. This is my first post on this forum. We have written a software test tool to test the calls for an API we are developing for a medical market. We are going to follow 62304 for the API but unsure if we need to follow 62304 for writing the test tool. We know that we need to validate the tool, but do we need to follow the entire 62304 process for writing the tool? Can you refer me to any official document, i.e. a standard or guidance doc that addresses this scenario? Thank you and I look forward to your response.