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  • I3CGLOBAL
    510k Executive Summary and 510k Summary   A 510(k) Summary provides a brief summary of the device included in the premarket notification and the supporting information. It must be in sufficient detail to provide an understanding of the
  • I3CGLOBAL
    The animal studies utilized for the assessment of the devices initial evidence of device safety, their potential performance when used in a living system, and the biologic response that a living system may mount towards the device. If
  • I3CGLOBAL
    Clinical Information means all data, reports, writings, research, and calculations performed using a device in scope. Out put is called as clinical data.  Clinical study is conducted to collect data to establish safety and effectiveness of investigational devices.
  • I3CGLOBAL
    UKCA Mark Labelling Requirements   UKCA mark or a CE Mark logo is a must depending on which legislation the device has been certified under. The Certificate issuing Notified Body or Approved Body number must also appear on
  • ShareThoughts
    EU Registration for Face Masks : face masks usually fall into two categories – Medical Face Masks and Respirators. Medical Masks intended to stop cross contamination between user and patient  fall under MDD directives. Respiratory Masks intended to
  • ShareThoughts
    EU Registration for Gloves: Examination Gloves fall under the Class I category of Medical devices intended for use in the medical field to protect users and patients from any possible cross-contamination and can be self-certified according to MDD
  • ShareThoughts
    Class I Medical Device EU Registration : If a manufacturer plans to market their product in the EU market, the manufacturer has to ensure their product complies with the relevant European Directives set by the European Commission. Medical Devices
  • 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

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