When working on a project, I prefer to be part of a small team rather than a large one. Small teams usually have clearer communication and fewer misun...

I prefer working under a project manager who primarily communicates online. Online communication allows for more flexibility, especially for team memb...

In my opinion, some people have innate leadership traits such as confidence, responsibility, and the ability to influence others, which represents the...

Effective communication starts with setting expectations and defining roles at the beginning of the project. Regular meetings or check-ins can help en...

I believe that the most important responsibility of the FDA is ensuring the safety and effectiveness of drugs, food, and medical devices before they r...

On my opinion, having a basic understanding of project management helps individuals know their responsibilities and how their work affects others. In ...

Implementing a risk management device assessment for medical device helps identify potential hazards early, reducing the chance of device failure or p...

As an example of a hazard in would be electrical hazard in a hospital can occur when a patient monitoring device has a faulty power cable. the hazard...

Risk management is a controlled process to identify and reduce potential hazards in medical devices. It ensures product safety. Medical devices compan...

The Design Input Document (DID) and Design Specification Document (DSD) are both important for developing a medical device, but they serve different p...

Design control helps reduce potential risks by ensuring that every stage of the medical device design process is properly planned, reviewed, and docum...

I haven’t participated in an audit yet. The main difference between DHF and DHR is that The Device History File (DHF) includes all design and developm...

Verification and validation sound similar, but they mean different things. Verification checks if the product was made right based on the design and r...

Without strong design control, medical device can become risky because it helps keep the whole process organized and safe. If it’s not done properly, ...