NELSPACE — MedTech
What is your software intended to do?
We start with the software’s outputs and the decisions it should help people make. The discussion also covers AI and the data used.
- 01Describe the intended use, users and the software’s role in clinical decisions.
- 02Compare the product description, instructions and advertised uses.
- 03Identify the MDR or IVDR questions to investigate and agree the next step with NELSPACE.
30 minutes, with no commitment. One use case is enough to start.
Let’s prepare your conversation.
Following your reading: Your software is used in healthcare. Does that make it a medical device?