We've been developing a wearable, which is classified as a medical device, so we've been looking at the FCC/CE/etc regulations for a while.
We're using ESP32s, and are currently going through ethics approval, which, from what I understand, means we can use the device prior to sale, but maybe we've got that wrong. I can't imagine having to have each hardware iteration certified by the FCC.
What struck me more about this article is the subject of marketing.
For companies that are doing pre-sales, and are still in development, and likely haven't been certified yet. Isn't that considered marketing? How are other companies handling this? We're looking to run a marketing trial in a few months, and marketing is part of the recruitment process for a trial.
Ethics approval for a medical device is a completely different thing from EMC regulations (which is what normally people mean when talking about FCC and CE for a device).
"I can't imagine having to have each hardware iteration certified by the FCC."
Depending on your device and the magnitude of the changes, this might simply be the reality for you. This is why I always try to tell people that you need compliance at the table from the start or you really risk making life very difficult for yourself. Find yourself a compliance specialist or at least a hardware engineer who is familiar with the regulations.
EDIT: You CAN'T just iterate ad-infinitum for free without consequence like you do for software. This thinking and approach, only works in software land. No where else.
It would be ridiculous to build a house and having the builder iterate on your house over 2-3 years to finish it, no?
We're using ESP32s, and are currently going through ethics approval, which, from what I understand, means we can use the device prior to sale, but maybe we've got that wrong. I can't imagine having to have each hardware iteration certified by the FCC.
What struck me more about this article is the subject of marketing.
For companies that are doing pre-sales, and are still in development, and likely haven't been certified yet. Isn't that considered marketing? How are other companies handling this? We're looking to run a marketing trial in a few months, and marketing is part of the recruitment process for a trial.