I agree that clearer limits might help, but one thing that hasn’t been mentioned is how inconsistent a single numerical cap would be across regions. A...

One thing I don’t think has been brought up yet is how verbal agreements become risky simply because people change. Teams shift, managers leave, and p...

One thing I think hasn’t been mentioned yet is that a consulting agreement can become risky even when the contract itself looks perfectly compliant. R...

Another important factor is the extent to which the team's members influence whether leadership or management works better. Different personalities re...

I think a big reason teams struggle to connect Design Controls with Project Management is simply that most engineers were never really trained in PM t...

Something I think doesn’t get talked about enough is how much the environment affects whether someone actually feels comfortable speaking up. It’s not...

One issue I see with depending too much on FMEAs is that they are predicated on the idea that failures occur one component at a time in predictable wa...

One thing that often gets overlooked is that risk isn’t just tied to the device design but it’s tied to the patient using it. Two people with the same...

Sometimes a mitigation doesn’t make the product safer overall, it just transfers the risk to a different user group, workflow, or failure mode. For ex...

Everyone’s shared great technical solutions, but another issue behind documentation fatigue is how people interact with the process, not just the tool...

Everyone’s made great points about prediction limits and company oversight. Another major gap is that verification and validation don’t really reflect...

While many have raised valid points about adaptive algorithms and overconfidence in structured systems, I think a modern “Therac moment” could result ...

I agree with everyone that design controls don’t have to kill creativity - it really depends on how teams use them. One idea I haven’t seen mentioned ...

I agree that multiple design reviews are needed, especially at major milestones like inputs, outputs, and validation. But to answer your question abou...

I like how you mentioned the importance of using documents like the DID and DSD to turn user needs into measurable specs. Something that also works gr...