Medical devices differ more in the level of design review and testing than in the designs per se - many of them are fairly straightforward. As long as 3rd par

Medical devices differ more in the level of design review and testing than in the designs per se - many of them are fairly straightforward. As long as 3rd party repair a) doesn't cut corners and b) knows how to do full verification testing, it should be fine. The latter part is interesting, as public side of FDA filings doesn't have all the V&V filings. I suspect that's why FDA is less sanguine about re-manufacturing.