In this paper, you will learn how medical device manufacturers use Polarion to achieve IEC 62304 and FDA compliance. Here is just a sample of what is covered: Easy-to-use industry proven processes — right out of the box Configurable and secure workflow with automatic revision control ...
Templates for ISO 13485, IEC 62304, ISO 14971 and ISO 62366 compliance. These are markdown files. If you prefer to download them as .docx, .pdf, and .html files, head over to our website at openregulatory.com/templates. Rationale Regulatory compliance is an opaque field, riddled with sub...