I think for medical device companies the decision to go in the route of an S Corporation or C corporations depends on what the company values and their plans for growth or development. In the early st...

Having some exposure to the corporate veil from an engineering law class, I think the corporate veil is very important for owners of a company to be able to separate the liabilities of a company from ...

So I think to some degree there is definitely an moral question here over whether or not it is unethical for a company to withhold a medical device if it does not meet a 70-80%, especially if this dev...

So, I believe that its hard to definitively say which should have more resources allocated to the other. Both are equally as important in my opinion to ensuring product safety of the device. Quality a...

I have always believed that QA and QC are fundamentally important for well functioning device and or company. My thought have not really changed after the lecture and they've really only been reinforc...

As we are aware, medical device development is a long and in depth process from early prototyping, to clinical trials, and evaluations before its eventual release to market. Within every stage of deve...

I think the FDA handled the vaccine rollout as best as they could given the circumstances at the time. Like many others have said here, it wasn't a perfect rollout, but it was quite well done given th...

The FDA medical device classification system (Class 1, 2 and 3) have been in place for many years and is based upon the level of risk a device poses to a patient. However, with the advance of technolo...

I think that its really hard to say if one side dominates over the other in terms of whether regulations slow down medical device development or help innovation. I think regulations equally slow down ...

Cutting corners in industry or in research, especially in preclinical trials, is an incredibly dangerous practice and should not be common place. Even if there are budget or deadline constraints, corn...

Animal testing is certainly a contentious topic with some claiming it is unethical and calling for animal testing to end while others claim it is a necessary evil for the betterment of science and tec...

I think that utilizing different species is not necessarily a bad thing when it comes to preclinical studies. As many have pointed out already it is important to recognize that there will be differenc...

To preface this response, unforeseen circumstances can always arise during an endeavor such as a project. In fact, it is not uncommon to have an issue arise in a project especially during the executin...

I think this has been echoed by a lot of the posts above, but I think establishing the scope early in the project, likely during the initiating or planning phase, is the best course of action in order...

In terms of teams in general, I think that the most important factor is that there is mutual respect for both team members and project managers. I think trust and communication is a very important fac...