I agree that avoidance is often the way that is preferred in manufacturing because preventing a risk before it happens is the most reliable way to pro...

To put a plan into action, I would focus on using tools and methods that help me stay organized about potential problems. I would start with a detaile...

This post brings up an important point about whether the use of FMEA has become too rigid for the reality of modern devices. FMEA is a useful starting...

Rebuilding a design history file for a legacy combination product can be hard especially when the original documentation isn't finished or does not ex...

A contract manufacturer plays a important role in process validation by giving documented evidence that the manufacturing equipment, processes, and co...

Even though verification and validation may seem similar, they do serve different purposes. Verification is focused on confirming that the design meet...

The best way to translate a qualitative user need into a testable and quantitive design input is by breaking it down into measurable criteria. To main...

I think that multiple design reviews should be held throughout the development process. Each stage of design can reveal different issues that might no...

I think design controls can actually support innovation when they are utilized in the correct way. Although ISO 13485 and FDA 21 CFR 820 seem rigid, t...

Clinical studies are crucial in advancing medicine because they give the evidence necessary to determine whether new drugs and medical devices are eff...

The placebo effect can complicate clinical trials because it makes it harder to tell whether improvements in patients are because of the actual drug o...

I think participants in pharmaceutical trials should receive compensation in some situations if it is ethical. The compensation should be based on the...

Participation in marketing is when brands invite customers to help shape their products. Crumbl cookies for example use changing their cookies once a ...

Personally, as a biomedical engineer, I would choose marketing after an engineering role. I think I would be able to use my background to understand c...

I do agree that color is one of the most crucial tools that is used in branding because they appeal to consumers. For example coca-cola uses red becau...