That regulation is onerous on purpose, to prevent fly-by-night tech companies to sell expensive medical equipment that may end up hurting people. The medical devices industry runs slowly by design (see the cheap-wheelchair episode of Seinfeld for one example of how this goes wrong)
That regulation is onerous on purpose, to prevent fly-by-night tech companies to sell expensive medical equipment that may end up hurting people. The medical devices industry runs slowly by design (see the cheap-wheelchair episode of Seinfeld for one example of how this goes wrong)