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 be helpful for protecting sensitive details, but th...

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 decisions. Bringing a spouse to a business dinner 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 prove what each person said or promised. Verbal and ...

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 managers for resources. This makes decision-making...

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, but it’s not always the best choice if they don’t ha...

I think project teams struggle to integrate Design Controls with Project Management because the two systems are usually treated separately and handled by different groups.Design Controls get more atte...

Implementing a risk management device assessment for medical device helps identify potential hazards early, reducing the chance of device failure or patient harm. A clear risk management plan outlines...

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 is the damage cable itself . The hazardous situat...

Risk management is a controlled process to identify and reduce potential hazards in medical devices. It ensures product safety. Medical devices companies are responsible for managing risks because it ...

The Design Input Document (DID) and Design Specification Document (DSD) are both important for developing a medical device, but they serve different purposes. The DID provides a broad overview of the ...

Design control helps reduce potential risks by ensuring that every stage of the medical device design process is properly planned, reviewed, and documented. It allows teams to identify and address pot...

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 development records that show how the medical device was c...

If ISO and FDA don’t set a required number of design review meetings, how can teams decide when they have done enough reviews? Do you think one review is enough to ensure that a medical device design ...

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

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, many problems can happen, like design mistakes or ...