Last seen: Nov 30, 2025
Verbal contracts do have their place in the field, but shouldn't be realized on too heavily. As was mentioned, verbal agreements have a lack of tracea...
Loopholes will always exist in every area where there are restrictions. As mentioned, the cost of a "gift" is a bit irrelevant if the intent behind th...
NDAs are indeed a necessary tool to protect a company or person's IP, however they are used aggressively. Maybe this isn't a bad thing, but in the med...
Matrix organization is successful only when everyone's perspective is aligned to a single, shared goal. Clear boundaries between each manager is impor...
I think that speaking up to a project lead depends greatly on how you phase what you want to say, instead of the content of what you want to say. Many...
Design controls are process-driven, while project management is behavior-driven. Design controls rely heavily on regulatory, while project management ...
Mistake-proofing shouldn't be intrusive in a way which disrupts workflow. The best types of mistake-proofing are ones which are seamlessly integrated ...
One thing which I think is also important to consider is the user's perception of the device if the device is "over-engineered" to mitigate risk. For ...
To build upon what was mentioned in the post before mine, FMEAs are only as effective as the team who constructed it. Relying on checklists can be the...
What contributed to the Therac-25 incidents was a reliance on old code as mentioned in previous posts. Engineers possibly assumed their code from prev...
Following design controls intentionally is important for efficiency, even if it feels like it's there just for compliance. A lot of it feels like regu...
As briefly mentioned, sectioning off the DDP by "departments" will allow the file to be filtered to view what is relevant to an individual or team. Fi...
To coordinate between risk and verification validation results, a dynamic risk assessment system can be used to consider the results. Verification and...
FDA and ISO should begin to change their requirements. All of their requirements were written where the submissions were done in concrete steps. Many ...
Engineers should "fight" for an ideal design in a way which describes their design as a benefit to the business. In design, usually user needs will co...