Before signing an NDA, I think it’s important to understand exactly what information you’re agreeing to keep confidential and for how long. NDAs can b...

I understand why these rules feel strict, but they are there to prevent any situation that looks like a company is trying to influence a physician’s d...

Verbal agreements can be legal, but they are not very reliable because nothing is written down. If a disagreement happens later, it becomes hard to pr...

In my opinion, being a project manager in a Matrix organization is harder.The PM has to deal with two bosses and constantly negotiate with functional ...

I would choose members based on their skills and how much they can contribute to the project. Working with people you know well can be comfortable, bu...

I think project teams struggle to integrate Design Controls with Project Management because the two systems are usually treated separately and handled...

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, ...