Medical Devices Quality Management Systems
QM083
KIHT Certification Services
Address C/o Kalam Institute of Health Technology, AMTZ Campus, Pragathi Maidan, VM Steel Project, S.O. Visakhapatnam - 530031, Andhra Pradesh, India
Contact Person Mr. Kilari Udayabhaskar
Designation Scientist – D
Tel +91-8885092133
Fax
Email ID bhaskar.k@kiht.in
Website https://kiht.in
Valid From April 05, 2024
Valid Upto April 04, 2027
Accreditation Standard ISO/IEC 17021-1:2015 and IAF MD 9
 
Scopes of accreditation
Main Technical Areas
(as per IAF MD 8:2023) 		Description
(Main Technical Areas) 		Technical Areas
A1.1 Non-Active Medical Devices Non-active medical devices other than specified above
A1.5 Sterilization Methods for Medical Devices Ethylene oxide gas sterilization (EOG)
Moist heat
Radiation sterilization (e.g. gamma, x-ray, electron beam)
Low temperature steam and formaldehyde sterilization
Thermic sterilization with dry heat
Sterilization with hydrogen peroxide
Sterilization method other than specified above
A1.6 Devices incorporating/utilizing specific substances/ technologies Medical devices incorporating medicinal substance
Medical devices utilizing micromechanics
Medical devices utilizing nanomaterials
Medical devices incorporating or utilizing specific substances/technologies/elements, other than specified above
A1.7 Parts or services Raw materials
Components
Calibration services
Distribution services
Transportation services
Other services
 
 
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