Medical Devices Quality Management Systems
QM 010
TUV Rheinland (India) Pvt. Ltd.
Address 27/B, 2nd Cross Road, Electronics City, Phase- 1, Bangalore - 560 100, India
Contact Person Mr. M.Bhaskar Mr. Dayanand K R
Designation Director, Finance and General Administration Assistant General Manager
Tel + 91 80 3055 4345 +91-80-46498031
Fax +91 80 3055 4342 +91-80-46498042
Email ID,
Valid From 31 July 2017
Valid Upto 15 August 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
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
A1.5 Sterilization Methods 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
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