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...

There is a conflict when it comes to honest/proper communication and using the nocebo or placebo effect as a therapeutic tool. Patients entering a cli...

Clinical trials are indeed very long and very expensive because of the ethics, regulatory demands, and demands for solid results which go into each cl...

As mentioned, a blinded study is a bit difficult to have honest conversations with the patient as it could compromise the study integrity. If a patien...