Preparation of technical and operational documentation

ORGANIZATION OF MEDICAL DEVICE TESTING

Medalis LLC arranges all necessary tests, among them technical, toxicological, clinical and electromagnetic compatibility tests. Our team supervises the process of testing in its entirety and examines all test results for regulatory compliance. We only collaborate with laboratories that members of our group and have been accredited in accordance with the current national and international legislation.

LIST OF TESTS

• ARRANGEMENT OF TECHNICAL TESTS FOR MEDICAL DEVICES

  
  

  Our team arranges and provides support for technical tests of medical devices, performed by the testing laboratory, in order to check the regulatory compliance of technical and operational characteristics of a medical device, as well as its technical and operational compliance.
  Medalis LLC is a member of the group along with Electrontest LLC, an equipment safety testing laboratory, whose main activity is to carry out technical acceptance tests of medical devices for their registration in the Russian Federation and EAEU.




• ARRANGEMENT OF TOXICOLOGICAL STUDIES OF MEDICAL DEVICES

  
  

  Our team arranges and provides support for toxicological tests of medical devices in the testing laboratory of ElectrontestBio LLC to confirm the safety of materials contained in the medical device being registered that come into contact with the human body. ElectrontestBio LLC is a testing laboratory, whose main activity is biological safety testing of medical devices and drugs.
  
  ElectronTestBio LLC testing laboratory comprises:

  • Chemical and Analytical Research Division;
  • Microbiological Research Division;
  • Toxicological Research Division;




• ARRANGEMENT OF ELECTROMAGNETIC COMPATIBILITY (EMC) TESTS OF MEDICAL DEVICES

  
  

  Our team provides support for EMC tests of medical devices at the testing laboratory for the purpose of evaluation of a medical device’s compliance with technical regulatory requirements and national standards in terms of electromagnetic compatibility of the devices.




• ARRANGEMENT OF CLINICAL TRIALS OF MEDICAL DEVICES

  
  

  Our team arranges and provides support for clinical trials of medical devices at accredited medical organizations in order to perform a comprehensive practical examination of a medical device, and to confirm its safety and performance qualities. Clinical trials are globally considered to be an essential stage in the development of medical devices that precedes their registration and widespread medical use.