I have a question for you, and want to ask for your opinion.
We are an AI software team in a *** hospital. Our product is similar to ***. Our pneumothorax algorithm could automatically identifies findings suggestive of Pneumothorax based on chest X-ray scans and outputs an alert.
Because this product is a pure software, i.e. SaMD(Software and medical device), we do not manufacture physical medical equipment and don't have some activities. For example, there is no sterilization activity in our production processes.
I would like to know what documents are mandatory for a SaMD to develop a QMS?
Looking forward to hearing from you