Currently, my team is in the middle stages of our product development project. We have all submitted first drafts of our documents to each other for review, so that we can make required editations bef...

In starting my own company, I think the functional matrix organization structure makes then most sense. Having departments structured and separated by function would allow every aspect of the developm...

I don't have an abundance of experience operating in different organization types, however I do feel that the most effective in my opinion would be a rigidly organized structure. While the "everyone d...

Much of what we have learned about risk management uses terms like "minimize" and "as much as possible" due to the nature of risk. Risk is something that can never completely go away. Some amount of r...

Post-Market surveillance is important for medical devices of all classifications, and additionally all products in general. This goes back to the statement that risk management does not have a specifi...

Quantifying risk in product development is incredibly important for the project to stay on track successfully. This is not always an easy task, which is why there are methods like the SWOT analysis me...

You have encompassed just about all of what goes into risk assessment with the two categories of "how often the failure occurs" and "severity of the failure." However, both of these could be expanded ...

As a project manager, the main this I would be looking for in a risk assessment meeting is input and feedback from everyone. Obviously as the project manager, I would have a good idea of the risk assu...

Determining the sample size for validation protocols seems to be a somewhat neglected, but very important task. The biggest reason this task proves to be difficult is the ability to properly analyze r...

From my experience working on a Gantt Chart, the most important thing to consider is the relationship between tasks. Many tasks depend on other tasks completion before they can be finished, or even st...

Design verification and validation are very similar, and I struggled to grasp why they needed to be separated into two distinct phases as well, when they seem be almost the same thing. What I have lea...

Design Controls organize everything about a product, and the product development stages. The importance of proper design controls stems back to the importance of communication. Design controls play a ...

Obviously, I think all parts of the DDP are essential. If they were not, by now they would likely be obsolete. However, out of all of them, I agree, the Communication management is the most essential ...

Design Controls are important for any product development project. However, just any Design Controls thrown together haphazardly and insufficiently will not suffice. Design Controls are the blueprints...

The Design Input Document is the foundation of any product development project. It contains the basic functionality requirements and details of the product. Because of the amount of information that n...