Medical Devices Quality Management Systems
QM 006
IRCLASS Systems and Solutions Private Limited
(Indian Register Quality Systems)
Address 2nd Floor, New Building, 52 A, Adi Shankaracharya Marg, Opposite Powai Lake, Powai, Mumbai - 400 072.
Contact Person 1 Mr. Shashi Nath Mishra
Designation Head - IRQS
Contact Person 2 Mr. K. Doraiswamy
Designation Deputy General Manager
Tel  +91 22 3051 9800 / 3051 9802 / 3051 9836
Fax + 91 22 3051 9826
Email ID irqs@irclass.org
Website www.irqs.co.in
Valid From 17 September 2021
Valid Upto 18 April 2027
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
Devices for wound care
Non-active dental devices and accessories
Non-active medical devices other than specified above
A1.2 Active (Non Implantable) medical
devices
General active medical devices
Monitoring devices
Active (non-implantable) medical devices other than specified above
A1.5 Sterilization Method for Medical Devices Moist heat
Radiation sterilization (e.g. gamma, x-ray, electron beam)
Thermic sterilization with dry heat
Sterilization method other than specified above
A1.7 Parts or Services Distribution services
 
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