I think biomedical engineers play a role in the entire feedback system that determines whether a clinical trial can evolve efficiently. In Dr. Simon’s...

I love this topic regarding the psychological aspects of clinical research. Dr. Simon and the provided protocol template discuss the importance of red...

I agree with both of you that the complexity of clinical research makes everything more time-consuming and stems from the ethical and regulatory layer...

If I were to create a company, it would be a physician-led medical technology company. I would be the physician, and this company would design and cre...

Hi @atmeh-njit! Excellent post and question. I totally agree that marketing is essential, but also very risky in the medical device field. Marketing i...

Thanks for the scenario! I agree with Krish, I would do a Limited Liability Company (LLC) that would likely be taxed as an S-Corp instead of a sole pr...

I agree with everyone's response regarding the need for engineers to understand the regulatory basics in order to create products that don't need revi...

EUDAMED is a big step towards transparency with medical devices. Even after a year from the last post in this forum, EUDAMED is still not fully operat...