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Medical device manufacturer

medical device manufacturer

EU's Medical Device Regulation (MDR) not only expands the medical device definition to a large list of products but also includes a reclassification for the old list. According to this, maybe you are a medical device manufacturer if your product is now a medical device (thinking on healthcare apps or wearable devices)

If you are considered a medical device manufacturer, you shall place your legal name and adress close to the symbol in the labelling of the product.

But who is the actual manufacturer of a medical device product? Manufacturers of medical devices take prime responsibility for getting their products CE-marked for the European market. The manufacture is to clarify how the company is affected: legal entities, obligation of economic operators, organisational structures and resources.

Medical devops manufacturing software ERP is an optimal solution to cover all the aspects that a medical device manufacturer needs.