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Questionnaire For ISO 13485: List of Devices Covered Under The Applied Scope of Certification

This document is a questionnaire for ISO 13485 certification that covers three medical devices: an Advance ICU Ventilator, a Harmonized Ventilator System, and a Non Invasive Mini Ventilator. It lists the intended uses and technical areas of each device. The company provides design, manufacturing, installation, and sterilization services. Product testing includes calibration and final inspection checks. The authorized representative signs to confirm the information.

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Neha Ukale
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76 views1 page

Questionnaire For ISO 13485: List of Devices Covered Under The Applied Scope of Certification

This document is a questionnaire for ISO 13485 certification that covers three medical devices: an Advance ICU Ventilator, a Harmonized Ventilator System, and a Non Invasive Mini Ventilator. It lists the intended uses and technical areas of each device. The company provides design, manufacturing, installation, and sterilization services. Product testing includes calibration and final inspection checks. The authorized representative signs to confirm the information.

Uploaded by

Neha Ukale
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Questionnaire for ISO 13485

List of Devices covered under the applied Scope of Certification:

Medical Devices Technical Areas


Name and Detailed Description of the
Intended Use (As per enclosed Guideline for
Medical Device / Medical Device Family
MDTA – IAF MD9 )
Advance ICU Ventilator- AVS Model The Advance ICU Ventilator Systems is Design
(Compressor Based) intended for treating and monitoring Manufacturing
universal patients with respiratory failure or
respiratory insufficiency.
Harmonized Ventilator System- HVS Model The Harmonised Ventilator Systems is Design
(With and Without Compressor) intended for treating and monitoring Manufacturing
Neonatal and pediatric patients with
respiratory failure or respiratory
insufficiency.
Non Invasive Mini Ventilator- ICVS Model The Non Invasive Mini Ventilator Systems is Design
(With and Without Compressor) intended for treating and monitoring Manufacturing
universal patients with ARDS or respiratory
insufficiency.

Design Responsibility : Self

Do you provide installation services : Yes

Used Sterilization Methods Steam Heat/ ISO Propyl Alcohol Solution (IPA)
Type of Product Testing requirements (if applicable) Calibration of pressure, oxygen and flow sensor.
Final inspection of machine with test lungs.

Signature of authorized Date: 27/12/2021


representative:

Name: Dipankar Aich Designation: Director

Note-1 : If the Application Questionnaire is filled electronically, no signature is required.

ZQAPL/F-01/13485/16-07-2021(Cl 9.1) – PART A (Questionnaire) Page 1 of 1

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