Quality Management Systems
QM 002
TUV India Pvt. Ltd.
Address 801, Raheja Plaza I
LSB Road, Ghatkopar(West),
Mumbai - 400 086.
Contact Person Mr. Rahul R Nayak
Designation Sr. General Manager (System Certification, Training & Sustainability)
Tel + 91 22 6647 7000 / 7010
Fax + 91 22 6647 7009
Email ID rahulnayak@tuv-nord.com
Website www.tuvindia.co.in
Valid From 22 May 2018
Valid Upto 11 Sep 2025
ISO/IEC 17021-1:2015 and IAF MD 9
Scopes of accreditation
ISO 13485 - Medical Devices Quality Management Systems
Main Technical Area as per IAF MD 8 Description (Main Technical Areas) Technical Areas
A1.1 Non-Active Medical Devices General non-active, nonimplantable medical devices
Non-active implants
Devices for wound care
Non-active dental devices and accessories
Non-active medical devices other than specified above
A1.2 Active (NonImplantable) medical devices General active medical devices
Devices for imaging
Monitoring devices
Devices for radiation therapy and thermo therapy
Active (non-implantable) medical devices other than specified
A 1.4 In Vitro Diagnostic Medical Devices Reagents and reagent products, calibrators and control materials for:
a) Clinical Chemistry
b) Immunochemistry (Immunology)
c) Haematology/Haemostasis/ Immunohematology
d) Microbiology
e) Infectious Immunology
f) Histology/Cytology
g) Genetic Testing
In Vitro Diagnostic Instruments and Software
IVD Medical Devices other than specified above
A1.7 Parts or Services Raw materials
Calibration services*
Distribution services
Maintenance services
Transportation services
Other services
Close Search Window