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 traceability, which is important in compliance with regu...

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 the gift stays the same. If the goal of implementing...

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 medical device field, one mess-up or leak in informat...

Matrix organization is successful only when everyone's perspective is aligned to a single, shared goal. Clear boundaries between each manager is important for determining when a manager runs out of au...

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 things which require speaking up have valid found...

Design controls are process-driven, while project management is behavior-driven. Design controls rely heavily on regulatory, while project management is primarily more business oriented. Dealing with ...

Mistake-proofing shouldn't be intrusive in a way which disrupts workflow. The best types of mistake-proofing are ones which are seamlessly integrated into non-mistake-proofed workflows. Overly rigid s...

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 the actual device, implementing all these features...

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 result of inexperience and/or the reluctance to c...

What contributed to the Therac-25 incidents was a reliance on old code as mentioned in previous posts. Engineers possibly assumed their code from previous projects was fine as is. With AI entering med...

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 regulatory checkboxes, but it can benefit a project te...

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. Filtering changes based on the specific sector the c...

To coordinate between risk and verification validation results, a dynamic risk assessment system can be used to consider the results. Verification and validation can uncover problems with a device rel...

FDA and ISO should begin to change their requirements. All of their requirements were written where the submissions were done in concrete steps. Many AI models have algorithms that can change after th...

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 complement business goals. For example, designing a ...