Kalyani Platina, 3rd Floor, Block I, No. 24, EPIP Zone, Phase II, Whitefield, Bengaluru-560066, India
Contact Person
Ms. Vinutha M.U
Designation
Quality Engineer
Tel
+91 80 41384400
Fax
+91 80 28413759
Email ID
Vinutha.mu@ul.com
Website
https://india.ul.com
Valid From
April 20, 2021
Valid Upto
April 19, 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, non-implantable 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)
* Organizations providing calibration services should be accredited to ISO/IEC 17025
