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| QM 062 |
| Zenith Quality Assessors Pvt. Ltd. |
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| 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 |
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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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