I think everyone here did a good job at breaking down the conceptual difference between hazards and hazardous situations. Something new I have to add ...

I like how everyone emphasized how important structure, preparation, and inclusion is in risk management meetings. I want to talk more about the forma...

Everyone has brought up excellent points about Poka-Yoke and how it reduces errors on the production floor. However, something that no one has touched...

I agree that design controls are more than a regulatory requirement in the sense that they are frameworks for quality and long-term communication. To ...

I think everyone made great points regarding documentation, calibration, and clear communication between the Original Equipment Manufacturers and the ...

I agree that the Therac-25 incident changed how we think about design controls; however, I think that the next "Therac moment” might come from overcon...

I am in agreement with what everyone has said so far, especially regarding the points about how collaboration and regulatory boundaries are imperative...

I agree that verification and validation have distinct purposes that keep the design controls objective and therefore reliable. Verification makes sur...

I liked the point regarding maintaining consistent QC and QA in transferring design control. I also agree that there is great importance in maintainin...

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...