Hi, After some advise.. we are manufacturers of procedure packs under article 12. For certain components that can not be sterilised or...
Hoping for some advice/comments regarding our difficulty sourcing a Notified Body (NB). Here's the situation: - We're not based in the EU, but...
Hi all, Is it a requirement to include/address the applicability or non-applicability of the following (from the MDD-M5) somewhere within the...
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