In this case, I think it depends on the scenario. If it is out of good will and genuine intentions, with no other intentions in mind, then the rules may seem a bit strict. They should be changed in so...

In my opinion, no verbal agreements should be taken as seriously as written agreements. There is no sense of commitment from either party. In reality, they are dangerous. Everything should be written ...

In terms of written vs verbal, a written agreement is much more evidential and easier to identify the certain terms of the agreement when it comes to legal matters. A verbal agreement can also be defe...

In my opinion, a matrix organization would be more difficult to work in especially as a project manager. Managing the constant communication between functional managers becomes a bit challenging since...

In a realistic scenario, you would want a management team that is filled with great leaders. People you can look up to, learn from, go to for advice/help, speak to in a friendly and professional manne...

The "two boss" situation can be completely avoided as long as the two individuals understand their priorities and the specific tasks/portions of the project that they are responsible for. Prior to any...

Accepting risk, to a certain extent, should be the case especially when the need is urgent and there are too many factors to consider as individual risks but there can be an overall calculated risk. I...

In reality, there are no 0-risk devices or products on the market in terms of the medical industry. Even devices that may have 100% success rates technically still have some type of risk. For example,...

At some point, there is a tradeoff between mitigating risk and actually increasing the risk through "mitigation techniques or processes." Of course, basic levels of mitigating risk are important to a ...

In general, there is a clear line between neglect and making mistakes. At times, people might change or alter a process and forget to note it down. Although this is also not the correct way of doing t...

At times, things like regulations may seem like barriers. But in reality, they aid in making a more robust device and reduce the chances of adverse effects (lower risk). At times, some regulations may...

Since they are two distinct aspects of the product development process, it is important that both are still completed. Although they do overlap, sometimes more significantly than in other cases, it is...

One issue that would arise is the failure of meeting its intended purpose. Without proper design controls, a product would most likely never make it to its end stages with proper functionality. Produc...

From what I have seen, most feedback can be influential and positive in terms of making a device or product better. Feedback can be in any form, and for the most part it is not a bad thing (if you do ...

I think this is a great question to consider since it is something that most of us, as engineers will eventually face. What is more important, user needs or the business limitations/needs. I think, in...