Effectively Communicating to FDA – being able to appropriately articulate what your software function is intended to do or intended to provide is –
the foundation – the corner stone – the linchpin to navigating the correct path, investing your resource wisely, and defending your decisions now and into the future. Solid foundations lead to solid futures.
Most companies can do a great job of providing a detailed engineering description of their product, but then come up way short on the clinical benefit side of the equation.
Your intended software function description needs to start to address:
- how does this benefit the patient
- how does this benefit the practitioner
- how does this benefit health care
