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Requirement of ISO 13485

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Guest user Created:   Jul 21, 2020 Last commented:   Jul 23, 2020

Requirement of ISO 13485

We are currently developing self-scanning application for a Thermal IR camera to help diagnose early-stage cancer as well as Pet care, with the help of AI.
I have a basic question here regarding ISO 13485, whether we will require this standard for our application or Not?

The concern has arisen as this application will give only indication/guidance to the user to go further to visit a doctor if there are any abnormalities/outliers using AI.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jul 23, 2020

If your device is a medical device according to the definition stated in the Medical device regulative (MDR 2017/745), then ISO 13485:2016 is applicable for you. ISO 13485:2016 is the only harmonized standard that is covering quality management system, and each manufacturer has an obligation to show compliance with applicable harmonized standards. 

For the definition see:

For the use of harmonized standard please refer to the following article

If you need any help for the implementation of the ISO 13485:2016, these materials can help

You can see our ISO 13485:2016 DOcumentation toolkit on following link: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

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Jul 21, 2020

Jul 23, 2020