I think tech lead or something like that. It sounds more serious than it actually is. Electrical engineering is done by someone who knows his stuff, I'm more software guy. Actual ADC is Texas Instruments chip built for ECG applications. So we basically interact with it and deliver a recorded signal to UI and finally to our servers. We have working business and we integrated with some ECG devices which are used on the local market, but having our own device would allow for much better integration and interesting features. Well, management always have infinite stream of ideas.
The hard part is going to be a certification, I guess.
If it's CE or FDA you're after, they are not that bad at all, I was tasked with it as an intern many moons ago and could complete both within 3 months starting from zero. It's a lot easier if it's the lowest level grade of medical device, otherwise you need clinical trials which are really difficult to organize. At the lowest level it's basically just a bunch of documentation you need to present to the authorities.
I think that we have our own certification processes in our country. I expect it to be mostly paperwork. We ensured some standard safety measures like galvanic isolation between human and potentially high voltage. But how it’ll go, I don’t know yet. It’s still lot of work for a complete device, especially with chip shortages.
Even as a class I device (which an ekg is emphatically never going to be), the ISO audit is three months between the first two stages alone. Under MDD 3 months is a push, but under MDR I think 6 is a much more realistic minimum (if you're starting from literal zero).
The hard part is going to be a certification, I guess.