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Declaration Of Conformity for EU Registration :The DOC or declaration of Conformity is an essential and mandatory document of the Read More
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Custom-made medical devices’ means any device specifically made in accordance with a written prescription of any person authorized by national Read More
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The sampling criteria: The main sampling criteria are lot sizes, inspection levels, acceptable quality levels, sample size code letters, and Read More
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Common Terms Used and their definitions are following Medical Device Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, Read More
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Information is published by Mrs. Neenu Jacob, Sr. Consultant (Medical Device Regulations) Email: nj@i3cglobal.in Sampling Size for Performance Testing Read More
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Above information is published by Mrs. Neenu Jacob, Sr. Consultant (Medical Device Regulations) email: nj@i3cglobal.in Barrier Performance Classification Read More
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The article was written and posted by Mrs. Neethu Anto, Sr. Consultant – FDA Regulation. (Email: na@i3cglobal.com) Automated Blood Read More
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European Authorized Representative (EAR) for EU Registration is a requirement according to EU MDR and EU IVDR for any Non-European Read More
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EU Registration Requirements for all Manufactures EU registration requirements: In order to commercially market or distribute a product intended for Read More