After working with a couple medical device companies, I believe my top requirements do not depend on the notion of public or private, but rather the e...

I appreciate that the original topic starter had mentioned thinking from the patient’s point of view. I believe this is a highly important notion for ...

@fh28 I agree with your perspective on the importance of diversity as well as varied expertise on an FDA expert panel! This is crucial as each member ...

The most common problem I face as a quality engineer intern are challenges due to document control. In other words, updating procedures, specification...

@dmf2 I respectfully disagree with the notion that the primary responsibility for addressing a damaged label should fall on the store. In my point of ...

Although it is tempting for me to say that post-market management is where the issues arise, I would argue that product development is the single most...

@sn64 In addition to these categories, an important comment I would like to make is that "Voluntary Action Indicated" (VAI) should be taken seriously...

I believe the extent of a professor's passions in academia and research depends on the individual professor, but often professors have a mix of these ...

I have been working as an intern in industry research for the last couple months and what I can gather is that it is generally heavily regulated by ag...

There are many hurdles that companies face when attempting to align themselves with ISO 10993's biocompatibility principles. First, medical devices ar...

Out of the qualities listed, I believe that personal organization is the most essential feature for a project manager. As the previous posts expressed...

Hi Jafar, I absolutely agree that having FDA Regulatory Consultant in medical device projects is essential. Medical devices are subject to strict re...

I have to disagree with most of these posts that immediately view missing a milestone as a failure. In my opinion, it depends on the circumstances pre...

I believe it is unlikely that Artificial Intelligence will "control" the medical industry, however, it will play an increasingly important role. One e...

On a scale from 1 to 10, where the viewpoint presented rates grades as a 1, I would personally place the importance of attaining good grades at around...