Medical Devices Quality Management Systems
QM082
Certification Association “Russian Register”
Address Russia 190121, Saint Petersburg, Rimskogo-Korsakova Prospect, 101, Office 1
Contact Person Mrs. Irina Dolgikh
Designation Head of International Activities Department
Tel +7 812 670 90 01 ext. 752
Fax +7 812 670 90 02
Email ID dolgikh@rusregister.ru
Website www.rusregister.ru
Valid From September 29, 2024
Valid Upto July 09, 2026
Accreditation Standard ISO/IEC 17021-1:2015 and IAF MD 9
 
Main Technical Area (as per IAF MD 8:2023) Description (Main Technical Area) Technical Areas
A1.1 Non-Active Medical Devices General non-active, non-implantable medical devices
Devices for wound care
Non-active medical devices other than specified above
A1.2 Active Medical Devices (Non-Implantable) General active medical devices
Monitoring devices
Active (non-implantable) medical devices other than specified above
A1.4 In Vitro Diagnostic Medical Devices (IVD) Reagents and reagent products, calibrators and control materials for:
  • Clinical Chemistry
  • Immunochemistry (Immunology)
  • Haematology / Haemostasis / Immunohematology
  • Microbiology
  • Infectious Immunology
  • Histology/Cytology
  • Genetic Testing
In Vitro Diagnostic Instruments and software
IVD medical devices other than specified above
A1.5 Sterilization Method for Medical Devices Radiation Sterilization (e.g. gamma, x-ray, electron beam)
Main Technical Area (as per IAF MD 8:2023) Description (Main Technical Area) Technical Areas
A1.7 Parts or services Maintenance services
Distribution services
Other services
 
 
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