Coming from a company that outsources many of their different drawings, outsourcing is crucial to the manufacturing of medical devices. One of the bes...

Clinical Research Study Manager was the job title that appeared when looking up Good Clinical Practices for me. The most common word I see in the job ...

I completely disagree that placebos are "negative" effects or "sham drugs". I think it's an overall depiction of how much we still don't know about th...

@archishak I agree that it is extremely important to have a competent team of cultured individuals to reach out to these specific populations. Not tha...

I would like to add to atk27@njit.edu response stating that although not required for a management position, it definitely does not hurt to have an MB...

I would say it all boils down to what social media platform you are using to push your device. It can be argued that social media such as TikTok or In...

Right off the bat, if you were to google what is a corporation, you would see "a legal entity that is separate and distinct from its owners" or "an or...

As a supplier quality engineer co-op (and working full time over the summer) for a relatively large biomedical company, I can confirm that specificity...

If any FDA/Regulatory class is considered "business," then I believe it should be added to the curriculum. Although the FDA medical device classificat...

I work as a Supplier Quality Engineer, where many different things come to my plate. I would say my main job is to work with nonconforming materials a...

I understand where the annoyance is coming from. As someone who works in quality, there are definitely outlines in the SOP for certain documentation t...

Working for a quality department that not only gets audited every couple of years, but also performs audits for their suppliers, many different factor...

I'd like to add that it all depends on the traceability of this error. Is this product CONSTANTLY having a label error where the sticker with informat...