The “Cost of Quality” is all about understanding that spending money on QA/QC upfront actually saves a company from far bigger losses down the road. A...

Quality Assurance (QA) uses preventive systems and processes to stop errors before they occur but Quality Control (QC) verifies finished products agai...

The QA department relies on document control to achieve audit-readiness for all project documentation which must comply with FDA regulations and other...

Yes, there are several examples of drugs that have been banned in the U.S. but are still available in Europe, Asia, or other regions. The evaluation p...

The FDA operates under established rules which serve as protective measures and also create restrictive barriers. On one side, they are essential for ...

The safety and effectiveness of drugs and medical devices depend on clinical trials as their fundamental research method. The organization of these tr...

When I think about research, I don’t see it as an either or between the future and the present. Both are important. Some research is focused on solvin...

I think cutting corners in research might save time in the short run, but it usually creates bigger problems later. If data is collected without prope...

I believe in industry, regulations are much stricter because the end goal is to bring a product to market for patients. Companies have to follow stand...

I believe project planing is important because it makes sure timelines, budgets, and milestones are clear from the start and regularly monitored. Tool...

The failure to reach a milestone does not necessarily indicate defeat. The results will emerge based on how the situation gets handled. The team might...

As I was going through the project management, I was thinking about how important the early phases are in medical device projects.The process becomes ...

I've encountered this argument multiple times and I believe it fails to recognize the essential contributions biomedical engineers make to their field...

Medical technology has experienced a major breakthrough through AI systems which now enable better disease detection at early stages. A startup compan...