Declaration Of Conformity for EU Registration :The DOC or declaration of Conformity is an essential and mandatory document of the Read More

Custom-made medical devices’ means any device specifically made in accordance with a written prescription of any person authorized by national Read More

 The sampling criteria: The main sampling criteria are lot sizes, inspection levels, acceptable quality levels, sample size code letters, and Read More

Common Terms Used and their definitions are following Medical Device Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, Read More

Information is published by Mrs. Neenu Jacob, Sr. Consultant (Medical Device Regulations) Email: nj@i3cglobal.in   Sampling Size for Performance Testing Read More

Above information is published by Mrs. Neenu Jacob, Sr. Consultant (Medical Device Regulations) email: nj@i3cglobal.in     Barrier Performance Classification Read More

The article was written and posted by Mrs. Neethu Anto, Sr. Consultant – FDA Regulation. (Email: na@i3cglobal.com)     Automated Blood Read More

European Authorized Representative (EAR) for EU Registration is a requirement according to EU MDR and EU IVDR for any Non-European Read More

EU Registration Requirements for all Manufactures EU registration requirements: In order to commercially market or distribute a product intended for Read More