Medical Devices Quality Management Systems
QM 011
TUV SUD South Asia Private Limited
Address TÜV SÜD House, Off Saki Vihar Road, Saki Naka, Andheri (East), Mumbai – 400072, India
Contact Person Mr. Rahul Kale
Designation Head of Certification body
Tel +91 20 6754 5555
Fax +91 22 6754 5575
Email ID
Valid From 16 Feb 2017
Valid Upto 28 April 2028
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 careNon-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
A1.3 Active Implantable Medical Devices General active implantable medical devices
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
A1.6 Devices Incorporating / Utilizing Specific Substances / Technologies Medical devices incorporating medicinal substances
Medical devices utilizing tissues of animal origin
Medical devices incorporating derivates of human blood
Medical devices utilizing micromechanics
Medical devices utilizing nanomaterials
Medical devices utilizing biological active coatings and/or materials or being wholly or mainly absorbed
Medical devices incorporating or utilizing specific substances/ technologies/ elements, other than specified above
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