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Covartim
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Covartim - Standalone Software

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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.

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  • 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.