QM092 – NABCB

Medical Devices Quality Management Systems

QM092

DI Quality Certification Services Pvt. Ltd.

Address	Plot no A-28, New door No. 18, 86th Street, 18th Avenue, Ashok Nagar, Chennai - 600083, Tamil Nadu, India
Contact Person	Ms. Jaya Yadav
Designation	Technical Head
Tel	+91- 8149717955
Fax
Email ID	jaya@diqcindia.com
Website
Valid From	March 21, 2025
Valid Upto	March 20, 2028
Accreditation Standards	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	Devices for wound care Non-active dental devices and accessories General non-active, non-implantable medical devices Non-active medical devices other than specified above
A1.2	Active (Non-Implantable) Medical Devices	General active medical devices Monitoring devices Active (non-implantable) medical devices other than specified above
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 IVD medical devices other than specified above
A1.5	Sterilization Method for Medical Devices	Radiation sterilization (e.g. gamma, x-ray, electron beam) Moist heat Thermic sterilization with dry heat Sterilization method other than specified above
A1.6		Medical devices incorporating medicinal substance Medical devices utilizing nanomaterials Medical devices utilizing micromechanics Medical devices incorporating or utilizing specific substances/technologies/elements, other than specified above
A1.7	Devices Incorporating/Utilizing Specific Substances/ Technologies	Components Calibration services Raw materials
	Devices Incorporating/Utilizing Specific Substances/ Technologies	Other services Transportation services Distribution services

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