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  • ShareThoughts
    Declaration Of Conformity for EU Registration :The DOC or declaration of Conformity is an essential and mandatory document of the European Product Directives for CE Marking that a manufacturer needs to sign to be able to declare that
  • ShareThoughts
    Custom-made medical devices’ means any device specifically made in accordance with a written prescription of any person authorized by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and
  • QARA
     The sampling criteria: The main sampling criteria are lot sizes, inspection levels, acceptable quality levels, sample size code letters, and acceptance and rejection points. Three types of sampling plans, single, double, and multiple. Three types of Inspection levels:
  • ShareThoughts
    Common Terms Used and their definitions are following Medical Device Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings
  • ShareThoughts
    Information is published by Mrs. Neenu Jacob, Sr. Consultant (Medical Device Regulations) Email: nj@i3cglobal.in   Sampling Size for Performance Testing (Bench Testing) – An detailed Overview The sampling plan provides an outline of how the testing is performed. It
  • ShareThoughts
    Above information is published by Mrs. Neenu Jacob, Sr. Consultant (Medical Device Regulations) email: nj@i3cglobal.in     Barrier Performance Classification of Medical Face Masks – An Overview The medical face masks are protective clothing designed to protect portions
  • QARA
    The article was written and posted by Mrs. Neethu Anto, Sr. Consultant – FDA Regulation. (Email: na@i3cglobal.com)     Automated Blood Cell Separator with Product Code ORG required 510(k) submission but under CBER. The Centre for Biologics Evaluation and
  • ShareThoughts
    European Authorized Representative (EAR) for EU Registration is a requirement according to EU MDR and EU IVDR for any Non-European manufacturer planning to commercially distribute or market their product in the European Union. The EAR is required to

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