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
Accreditation Standard
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 Components Subassemblies Calibration services*
Distribution services Maintenance services Transportation services Other services
