We do indeed. And we've done FMEA. We're in the midst of FDA clearance, so all the required quality work for product development is totally part of our process.
We're working on the assumption that regulatory processes establish benchmarks for performance, but they don't need to dictate how one makes things -- ie, design considerations can be front and center, not an afterthought.
We're working on the assumption that regulatory processes establish benchmarks for performance, but they don't need to dictate how one makes things -- ie, design considerations can be front and center, not an afterthought.