Almost all companies have an ethics/gift-giving policy in place. In these policies some of them allow you to take a client to a business dinner as lo...
This course provides valuable insight to what is expected in the medical device industry. As someone who has taken all of Dr. Simons courses I can hon...
“Despite popular belief, oral contracts are enforceable. They usually are not in your best interests, and end in a "he said, she said" battle. But as ...
I think being able to recognize this for your employees is a skill that is absolutely necessary in the hiring process when considering someone for a m...
I agree organization does influence company culture to an extent. However, I do think work culture is a big part of retaining employees. You want your...
Functional, project-based, and matrix organizations all have their individual advantages and disadvantages, as discussed per this week’s lecture. Most...
Our company offers several videos and training sessions that come with our product. The Training courses are, in my opinion, the best way to properly ...
I think it is important to look at risk from several different methods. My company uses a Risk Management Summary, Failure mode, effects and criticali...
In the position I am currently in I do a lot of Risk Analysis. This usually stems from investigations that open up when we are faced with a high failu...
The two common tools for project management schedule development are the Gantt and PERT chart. Both of these are great resources for planning and disp...
I do agree with you “Reviews can be formal or informal, require a well-prepared agenda, and can last hours, days, or even a few weeks.” However, this ...
Meeting minutes are used as documentation so that any attendee, or persons not present, that looks at this document can understand the basics of what ...
Like most of you mentioned before Validation and Verification are similar but the are not the same. In the verification process you are asking yoursel...
Unless your product has already been on the market, the FDA will not allow you to take your product to market if your Design Controls are not deemed s...
“The DHF is mandated by the U.S. FDA, and describes a product through its development cycle, under Design Control, with its output being the DMR (Devi...