Medical Devices Quality Management Systems
QM092
DI Quality Certification Services Pvt. Ltd.
Address 2nd Floor, Office No.232, VTP Trade Park, Katraj-Hadapsar Road, Undri, Pune 411060, Maharashtra, India
Contact Person Ms. Jaya Yadav
Designation Technical Head
Tel +91- 8149717955
Fax
Email ID jaya@diqcindia.com
Website
Valid From March 21, 2025
Valid Upto March 20, 2028
Accreditation Standards ISO/IEC 17021-1:2015 and IAF MD 9
 
Main Technical Areas (as per IAF MD 8:2023)
Description (Main Technical Area) Technical Areas
A1.1

Non-Active Medical Devices
• Devices for wound care
• Non-active dental devices and accessories
• General non-active, non-implantable medical devices
• Non-active medical devices other than specified above
• Non-active implants
A1.2

Active (Non-Implantable) Medical Devices
• General active medical devices
• Monitoring devices
• Active (non-implantable) medical devices other than specified above
A1.4

In-Vitro Diagnostic Medical Devices
• 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
• Radiation sterilization (e.g. gamma, x-ray, electron beam)
• Moist heat
• Thermic sterilization with dry heat
• Sterilization method other than specified above
• Ethylene oxide gas sterilization (EOG)
A1.6

Devices Incorporating/Utilizing Specific Substances/Technologies
• Medical devices incorporating medicinal substance
• Medical devices utilizing nanomaterials
• Medical devices utilizing micromechanics
• Medical devices incorporating or utilizing specific substances/technologies/elements, other than specified above
A1.7

Parts or Services
• Components
• Calibration services
• Raw materials
• Other services
• Transportation services
• Distribution services
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