AI for Health by Artefact

🇬🇧 How to bring a medical device software to the US market?

Description

Sim&Cure launched its medical device software Sim&Size (Class IIa) in Europe in early 2018. In 2019, the goal was to scale to the US market with a lot of topics to go through in particular with the funding, the FDA clearance, the US Team building & the Go To Market adaptation as the major ones.