 |
 |
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 9 |
|
|
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 |
|
|
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 |
A1.4 |
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
|
|
|
In Vitro Diagnostic Instruments and software |
|
|
IVD 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 |
A1.6 |
Devices Incorporating / Utilizing Specific Substances/ Technologies |
Medical devices incorporating medicinal substances |
A1.7 |
Parts or services |
Raw materials |
|
|
Components |
|
|
Subassemblies |
|
|
Calibration services* |
|
|
Distribution services |
|
|
Maintenance services |
|
|
Transportation services |
|
|
Other services |
|
* Organizations providing calibration services should be accredited to ISO/IEC 17025 |
|
 |
 |