Medical Devices Quality Management Systems
QM 001
DNV Business Assurance India Pvt. Ltd.
Address Registered Office:Equinox Business Park, Tower 3, 6th Floor, Off Bandra Kurla Complex, LBS Marg, Kurla (West), Mumbai - 400070 Operation Office: ROMA No. 10, G.S.T Road, Near Kathipara Flyover, Chennai - 600016
Contact Person 1. Mr. Sivadasan Madiyath Krishna Pillai 2. Mr. Navnath Pendurkar
Designation Operation & Technical Manager-India Subcontinent Area Manager- India Subcontinent
Mobile +91- 9825505449 +91-9823167348
Tel +91 265 2322622
Email ID

Valid From 10 March 2018
Valid Upto 20 Sept 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
Main Technical Areas
(as per IAF MD 8)
Description Technical Areas
A 1.1 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
A 1.2 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
A 1.4 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
A 1.5 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
A 1.6 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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