Quality Management Systems
QM 062
Zenith Quality Assessors Pvt. Ltd.
Address 01A, B-Wing, SIDDHESH OPTIMUS, S.No.211, Viman Nagar, Pune - 411 014, Maharashtra, India.
Contact Person Mr. Pradyut Bera
Designation Director
Tel +91 9607006692 / 9607006823 / 9607006973 / 9607006945 / 9607004749
Fax +91-20-41314107
Email ID pradyut@zenith-worldwide.com
Website www.zenith-worldwide.com
Valid From July 15, 2019
Valid Upto July 14, 2022
Accreditation Standard ISO/IEC 17021-1:2015 and IAF MD 8
 
Scopes of accreditation
ISO 13485:2016 - Medical Devices Quality Management Systems
Main Technical Areas (as per IAF MD 8) Description
1.1 Non-active Medical Devices
1.2 Active (Non-Implantable) Medical Devices
1.4 In-Vitro Diagnostic Medical Devices (IVD)
1.5 Sterilization Method for Medical Devices (except Aseptic processing)
1.6 Devices incorporating / utilizing specific substances / technologies (Medical devices incorporating medicinal substances only)
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