Last seen: Nov 26, 2019
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 r...
In starting my own company, I think the functional matrix organization structure makes then most sense. Having departments structured and separated by...
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 ...
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 t...
Post-Market surveillance is important for medical devices of all classifications, and additionally all products in general. This goes back to the stat...
Quantifying risk in product development is incredibly important for the project to stay on track successfully. This is not always an easy task, which ...
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 f...
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 ...
Determining the sample size for validation protocols seems to be a somewhat neglected, but very important task. The biggest reason this task proves to...
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 ...
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 t...
Design Controls organize everything about a product, and the product development stages. The importance of proper design controls stems back to the im...
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, t...
Design Controls are important for any product development project. However, just any Design Controls thrown together haphazardly and insufficiently wi...
The Design Input Document is the foundation of any product development project. It contains the basic functionality requirements and details of the pr...