Eldhojoseph
Registered
I'm very confused here because I'm a beginner and I saw some sources saying we need ISO just to be sure, and some other sources saying ISO or IEC are not mandatory if it's for wellness only.
Do I have to follow any standards if my EEG device is used only for wellness (non-therapeutic) uses in the USA and the EU
- Thread starter Eldhojoseph
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There's a lot of ISO standards (and IEC and ...). When you say "need ISO" - do you mean ISO 13485? FDA has adopted by reference.Is your device a (regulated) medical device (wellness devices get into gray areas and there's often a tendency to claim you're not a medical device just by asserting you have a wellness device.)
You're never legally bound to comply with any standards, even if you have a medical device that must meet regulatory requirements. Complying with relevant standards is the most logical path, in most all cases. Regardless, if you're putting a powered device on the market, you will likely want to comply with any relevant (e.g., electrical) to provide some assurance of basic safety.
You're never legally bound to comply with any standards, even if you have a medical device that must meet regulatory requirements. Complying with relevant standards is the most logical path, in most all cases. Regardless, if you're putting a powered device on the market, you will likely want to comply with any relevant (e.g., electrical) to provide some assurance of basic safety.
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