ECG Risk Analysis Standards

#1
Hi there,
I'm new in this area, I'm working on a portable ECG quality management system.
What are the standards that I should be complied with?
Do you have please examples of the quality management system and risk analysis?
Thanks
 
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yodon

Staff member
Super Moderator
#2
From the sound of your post, it seems you have nothing in place - no quality management system, no regulatory pathway defined, etc.? Your target markets also drive specific activities. Obviously, this is a huge discussion, not anything you can simply put in a post.

If your target market is the US then you have to comply with 21 CFR 820 (the Quality Systems Regulation). If you intend to market in the EU then your best path forward is to comply with ISO 13485. These are similar and converging but

For risk management, ISO 14971 is the best approach for risk management.

As medical electrical equipment, you'll need to comply with IEC 60601-1. That standard calls out both ANSI/AAMI/IEC 62366 for Usability Engineering and 62304 for Software Engineering.

Those are just the basics. I don't know the specifics for ECG equipment.

A word of caution: while it's understandable you ask for examples, it's a slippery slope. Devices and companies are unique and what works for someone may not work well for you. I would suggest you consider engaging with a consultant to get things kick-started.
 

primavesvera

Involved In Discussions
#3
To jump in, for the specific testing - IEC 60601-2-25, IEC 60601-2-27, or IEC 60601-2-47, depending on what is the intended use of the device.
If it is intended for the US market, check the FDA's guidance on specific ECG devices.
You might need to comply with IEC 60601-1-2 as well.

It really boils down to your intended use and the risks related to it.
 
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