Developing the team's culture and structure is, in my opinion, the key to enhancing the Quality Control (QC) division. Investing in training, not only...

The "Cost of Quality" truly makes it clear to me that QA/QC isn't just a department that slows things down; rather, it's a kind of insurance for the e...

When I initially thought of QA/QC, I mostly imagined it as a "final check" phase in which goods are simply evaluated to determine if they pass or fail...

One of the FDA's main challenges, in my opinion, is striking a balance between safety and innovation. On the one hand, the stringent regulatory proced...

Regarding the FDA's responsibility in "ensuring safety" as opposed to "guaranteeing safety," I believe you raise a very significant distinction. A med...

Recalls serve as a reminder that no system is flawless, even with FDA approval, and are a challenging yet crucial aspect of the medical device lifecyc...

Both industrial and academic research are vital, but they have quite distinct goals, which is why I think this is such an intriguing subject. Since it...

I concur that, although historically, research on animals has greatly advanced medicine and medical technology, employing live things for testing pres...

I believe that whether or not the work's safety and scientific integrity are upheld is what separates a good study from a bad one, even in cases where...

The best course of action when a team disagrees with a project manager's choice is to foster open communication while maintaining the project's object...

A project plan, in my opinion, gets overly complex when it begins to micromanage each little step instead of concentrating on the larger goals. Clearl...

Not meeting a milestone should be viewed as a failure in and of itself; rather, it should be assessed in light of the project's larger goals. Mileston...

If I were applying for a job, I would much prefer to be overqualified than satisfy the requirements. Being overqualified in the near term enables me t...

Based on my own experiences, I would advise Biomedical Engineering students to obtain work experience in the medical device sector, or actually in any...

I see a lot of benefit in obtaining medical device-related certifications, even for people whose main concentration may not be devices themselves, as ...