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   Scopes of accreditation Main Technical Areas (as per IAF MD 8:2023) Description (Main Technical Areas) Technical Areas A1.1 Non-Active Medical Devices General non-active, non-implantable medical devices Devices for wound care A1.2 Active Medical Devices (Non-Implantable) General active medical devices Monitoring devices 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 A1.5 Sterilization Methods for Medical Devices Radiation Sterilization (e.g. gamma, x-ray, electron beam) In Vitro Diagnostic Instruments and software A1.5 Sterilization Method for Medical Devices Radiation Sterilization (e.g. gamma, x-ray, electron beam) A1.7 Parts or services Maintenance services      Print   Close