Coming from a company that outsources many of their different drawings, outsourcing is crucial to the manufacturing of medical devices. One of the best benefits is that on a large scale, you can train...

What if I told you a company found the cure to the common cold, but it only works 50% of the time? What if a clinical trial (all stages) was performed and the drug outperformed the placebo? Now, what ...

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 description is "lead" or "oversee and execute" sho...

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 the human body, and how much we rely on pharmaceutic...

@archishak I agree that it is extremely important to have a competent team of cultured individuals to reach out to these specific populations. Not that it wouldn't be reasonable, but I would argue 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 MBA or some business background to show that one isn...

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 Instagram are places that have ads targeted more for...

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 organization - usually a group of people". This inv...

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 is much more prevalent. I spoke to someone recent...

If any FDA/Regulatory class is considered "business," then I believe it should be added to the curriculum. Although the FDA medical device classification is more relevant to people who are preparing t...

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 and disposition them according to what I think the ...

I understand where the annoyance is coming from. As someone who works in quality, there are definitely outlines in the SOP for certain documentation that seems almost too time consuming when the impor...

Working for a quality department that not only gets audited every couple of years, but also performs audits for their suppliers, many different factors come into play regarding errors that can be foun...

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 information is peeling/half-legible? Is it only one batch/...

As someone who works for a medical device company with a class III medical device, our company is required to be audited every two years for compliance. Through the auditing process, there are many st...