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What is a Medical Device?

The term "medical devices" includes everything from highly sophisticated computerized medical equipment down to simple wooden tongue depressors. The intended primary mode of action of a medical device on the human body, in contrast with that of medicinal products, is not metabolic, immunological, or pharmacological. But overall in broad sense can describe medical devices as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of

  • Diagnosis, prevention, monitoring, treatment, or alleviation of disease
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury
  • Investigation, replacement, modification, or support of the anatomy or of a physiological process
  • Supporting or sustaining life
  • Control of conception
  • Disinfection of medical devices
  • Providing information for medical purposes by means of in vitro examination of specimens derived from the human body and which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means.

LMG can assist you with

  • Medical Device Classification
  • Identification of MDD requirements
  • Identification of Harmonized standards
  • ISO 13485 Implementation
  • Identification of Notified Body
  • Technical File preparation
  • Technical File submission to Notified Body
  • Technical file re-submission
  • Assistance with Notified Body audit
  • Assistance in closing non-conformities
  • Affix CE Mark

 
LIBERTY MANAGEMENT GROUP LTD.
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E-mail : info@libertymanagement.us