Company Product safety
     

Product safety

 

 isoLogo

tga-logo

 

 

As a manufacturer of medical products Visiomed is subject to the Medical Device Act (MPG) of Germany. According to § 1 MPG this act primarily regulates the free movement of goods of medical products within the EU. The abidance to these thorough requirements, which are standardised within the EU through the European guideline 93/42/EWG, guarantee a high standard of 

  • Health protection
  • Efficiency
  • Safety for patients, users and third parties

The proven conformity of medical products (§14 MPG) with the fundamental requirements is documented by the products’ CE-labelling (§9 MPG). It depends on the products’ classification, i.e. the potential imperilment which can emanate from a medical product. 

Medical products are classified in four classes corresponding to their capability to injure the human body and the potential risks emanated from them: I, Ila, Ilb and III.  A declaration of conformity always consists of inspection and testing of EMV (electromagnetic compatibility) and a safety test.