Covartim - Standalone Software
A standalone software, such as a mobile or web application, can fall within the definition of a (IVD) medical device. Therefore, the placing on the market is well regulated and specific actions need to be undertaken.
- We analyse your product and determine if it qualifies as a (IVD) medical device. If so, we will conclude on its classification and the regulatory pathway.
- We manage the transition of a self-certified product under MDD to MDR.
- We assess impact of changes.
- We guide through the compliance to ISO 62304.