4 ms·
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
by ricardobayes 4y ago
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.
- vbezhenar 4y agoI 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.
- ealexhudson 4y agoEven 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).