Certification
  • Hassle free, no unnecessary delays
  • Individual approach to every costumer
  • Certificates and consent documents prepared in as little as 72 hours
About us

The Center of Certification Declaration, LLC will take care of all the necessary procedures for the medical equipment and health care product manufacturers as well as their dealers, so they can function effectively and continue with their day to day business activities without significant time loss and a minimum involvement in the routine process of registration and certification.

We are ready to assist through all the stages in obtaining all the necessary permits in federal government agency.
The entire range of services offered by Center of Certification Declaration, LLC is in compliance with the current legislation of Russian Federation and prepared in the shortest time possible:


-Certification of Medical Equipment and Supplies


-Registration for overseas and domestic manufacturing of medical equipment and supplies


-Testing (technical, toxicological, clinical, etc.)


-Development and coordination of technical terms/conditions


-Auditing of the quality systems in the medicine manufacturing facilities in compliance with GMP standards


-Consulting services for obtaining a license for manufacturing and maintenance for medical equipment


The Center of certification and declaration LLC has experience in registration of medical equipment and supplies in the territory of the Russian Federation and in the following ex-USSR countries: Ukraine, Belarus and Kazakhstan.
The Center of certification and declaration LLC is accredited by the Federal Agency for Technical Regulation and Metrology as the authority for certification of medical devices, the accreditation certificate POCC RU.0001.11IM41.

For more information

 

     
« » ()   « » ()   «» () «» ()
       
   
  «3M» ()  «» ()  OSSTEM ( )  «» ()
       
     
«» ()  «» ()  «» () «Nipro» () 
       
   
Atmos Medical GmbH ()  «» ()  «» ()  «» ()
       
       
« » ()  « » () Widex A.S. ()   «» ()

 



  • 01 December 2011