One key element of a quality system that directly impacts the safety and efficacy of medical devices is the inspections conducted during the productio...

Building on this discussion, it's essential to recognize that quality assurance (QA) has to prepare for both internal and external audits. The prim...

Finding a way to harmonize submissions in the biopharmaceutical industry is a challenge due to the varying requirements of regulatory agencies. In my ...

EUDAMED (European Database on Medical Devices) is an IT system created by the European Commission under the Medical Device Regulation (MDR) and the In...

In response to your question, the FDA's approach to minor errors in compliance during an audit depends on the severity and potential risk to public he...

I agree that the complex and rigorous regulatory process of medical device development is difficult for companies to navigate. This is where regulator...

As many mentioned, it’s clear that there are significant differences between academia and industry research, particularly in terms of how they use the...

In fields like biomedical engineering, while deep technical expertise may not be mandatory, having foundational knowledge is crucial for understanding...

I agree with many of the points made about the role of project managers and their need for strong communication and social skills. In my view, effecti...

In the medical device industry, beginning certain aspects of execution during the initiation phase can be crucial, particularly for preliminary testin...

While the question asks for an example of a corporation not complying with FDA regulations, I feel it’s important to highlight a broader issue—how the...

I agree with the perspective that there is no "golden ratio" for the balance between practical and academic courses, as it truly depends on each stude...