Medical Devices Quality Management Systems
QM 027
SGS India Pvt. Ltd.
Address Ecospace, Block 3A, 2nd Floor, East WIng, Premises IIF/11, Action Area - II, Rajarhat, New Town, Kolkata - 700160.
Contact Person Mr. Soumik Mondal
Tel  + 91 33 66506100/101
Fax + 91 33 22420745 / 22481745
Mobile 9908333499
Email ID
Valid From 24 Apr 2019
Valid Upto 15 October 2024
Accreditation Standard ISO/IEC 17021-1:2015 and IAF MD 9
Scopes of accreditation
ISO 13485 - Medical Devices Quality Management Systems
Main Technical Areas
(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) General active medical devices
Devices for imaging
Monitoring devices
Devices for radiation therapy and thermo therapy
Active (non-implantable) medical devices other than specified above
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
A1.5 Sterilization Method for Medical Devices Ethylene oxide gas sterilization (EOG)
Moist heat
Aseptic processing
Radiation sterilization (e.g. gamma, x-ray, electron beam)
Sterilization method other than specified above
A1.7 Parts or Services Raw materials
Calibration services*
Distribution services
Maintenance services
Transportation services
Other services
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