Last seen: Dec 1, 2024
There are several obvious things that companies would agree to keep confidential with a consulting firm. These include parts pertaining to intellectua...
Verbal contracts seem like a tricky part of the legal processes. There are several ways to ensure that verbal agreements are kept, though it may be di...
It seems absolutely necessary to have arrangements for how operations if something unfortunate were to happen to me as the owner or CEO of the company...
Unfortunately, in this organizational structure, there seems to be several issues. From the favoritism to the lack of concern for quality and regulato...
Upper management and middle management often fall into the blame game when it comes to the state of a company, especially a biomedical device company....
The original post in this thread raises an important point, but I believe there is a simple answer. While assembling a project team, it is important t...
Whether for a certain class or for personal research, I have certainly read some research papers, which after I read, I said "that should not have bee...
The industry and academia is an interesting Venn diagram in the realm of biomedical engineering. In terms of the qualities that one must have to posse...
The claim that one wants to perform research that has immediate effects and benefits seems to be somewhat flawed. The immediate benefits of a laborato...
Meeting minutes are one facet of the diamond I like to call personal responsibility in the workplace. It may seem tedious and unnecessary, but taking ...
From my work experience with a biomedical device that utilizes software, software validation is integral to the success of the device in the field. On...
I believe there needs to be clarification over the design control requirements by the FDA for class I, II, and III devices. The initial post in this t...
In my experience in the industry, I have seen the the importance and effects of both verification and validation. The first step in the journey of the...
It can be easily argued that a change notice is required for every proposed change to any document. It is a good practice for several reasons. It ensu...
I think that design controls "force" the company to be responsible for having a product that works and does not harm anyone. At the end of the day, bi...