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4,821 Posts.
2721
03/09/19
15:58
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Regulated vs non regulated devices / product.
Illumen is a non regulated product, not requiring CE mark or FDA approval.
Should you look to have your product used in the hospital / clinical environment, it needs to be a regulatory approved product.
The illumen product is quite different to what MEB's regulated product / screening will look like.
Worth going back and having a look at some older presentations from MEB. Clearly defines the three market segmentations.
Last edited by
13th:
03/09/19
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