Quality Management Systems
QM 028
MTIC Intercert India Pvt. Ltd. (Formerly called TUV Intercert Saar India Pvt. Ltd.)
Address No. 122/1, 3rd Main Road, Margosa Road, Malleswaram, Bangalore 560003
Contact Person Mrs. Aradhana Mishra                                              Mr. Rajesh Iyer
Designation GM - Food Safety and Certification In-charge        Managing Director
Tel 080-41285610
Fax 080-41285609
Mobile +91-9902826219
Email ID amishra@mtic-group.in
india@mtic-group.in
Website www.tuvintercert.in
Valid From 15 March 2019
Valid Upto 26 October 2024
Accreditation
Standard
ISO/IEC 17021-1:2015 and IAF MD 9
 
Scopes of accreditation
ISO 13485:2016 - 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 Medical Devices (Non-Implantable) Devices for imaging
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

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
 
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