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 (Non-Implantable) medical devices General active medical devices
A1.4 In-Vitro Diagnostic medical devices 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
A1.5 Sterilization Methods for Medical Devices Radiation Sterilization (e.g. gamma, x-ray, electron beam)
 
 
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