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.
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What we do
- 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.
Videos related to this software
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MedTech Meetup 2022 aftermovie - Video
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Medtech innovation in Belgium (2018) - Video
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The Belgian medtech ecosystem (2019) - Video
During the 2019 MedTech Meetup we asked two participants what they thought about the medtech ecosystem and its development in Belgium.
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Meet Alicia, QA/RA Associate at COVARTIM (in FR) - Video
Alicia joined COVARTIM in 2020 as Quality Assurance & Regulatory Affairs Associate. In this video she explains what she is in charge of and why she likes her job!
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