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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 9 |
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Scopes of accreditation
ISO 13485:2016 - 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 |
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Non-active implants |
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Devices for wound care |
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Non-active dental devices and accessories |
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Non-active medical devices other than specified above |
| A1.2 |
Active Medical Devices (Non-Implantable) |
General active medical devices |
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Devices for imaging |
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Monitoring devices |
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Devices for radiation therapy and thermo therapy |
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Active (non-implantable) medical devices other than specified above |
| A1.4 |
In Vitro Diagnostic Medical Devices (IVD) |
Reagents and reagent products, calibrators and control materials for:
- Clinical Chemistry
- Immunochemistry (Immunology)
- Haematology / Haemostasis / Immunohematology
- Microbiology
- Infectious Immunology
- Histology/Cytology
- Genetic Testing
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In Vitro Diagnostic Instruments and software |
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IVD medical devices other than specified above |
| A1.5 |
Sterilization Methods for Medical Devices |
Ethylene oxide gas sterilization (EOG) |
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Moist heat |
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Aseptic processing |
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Radiation sterilization (e.g. gamma, x-ray, electron beam) |
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Sterilization method other than specified above |
| A1.6 |
Devices Incorporating / Utilizing Specific Substances/ Technologies |
Medical devices incorporating medicinal substances |
| A1.7 |
Parts or services |
Raw materials |
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Components |
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Subassemblies |
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Calibration services* |
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Distribution services |
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Maintenance services |
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Transportation services |
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Other services |
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| * Organizations providing calibration services should be accredited to ISO/IEC 17025 |
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