One particular challenge that project managers face is time management. As the leader of the entire team who is responsible for the entire project, time management can be something that is particularl...

There are many factors that must be considered when evaluating a project change request. One such factor would be if the change would alter the business requirements. In other words, does the project ...

If the discussion doesn't produce a solution, then it should be tried again and again until it does because the project team is responsible for everything about the project. It's important for them to...

The Risk/Benefit Ratio is a way of comparing the risks of an action to the benefits that will come if that action is taken. If the benefits are relatively high compared to the risks, then it's mostly ...

One way to think about solving this problem is to brainstorm any potential risks that may arise while doing the actual project. I think that getting input from people who've had experience in doing th...

In my opinion, I think that it really depends on the milestone that you missed and what the results would've been had you not missed the milestone. Missing a milestone could make the project run easie...

Agreeing on the project goals is important because the team needs to understand the purpose behind the project and what is expected to come out of their efforts. If every team members understands what...

Another important measure that is important when considering the medical device is how frequently the device will be used by the user or how long the device will last. For instance, if the device is a...

Input from any different department (e.g. Marketing, Regulatory, Engineering) can only help in improving the efficiency of the device. There many be someone who doesn't offer a feasible specification ...

In case of an emergency, an unapproved medical device could be used if there is some enough that is has created positive results and has been tested in trials. As someone previously stated, there are ...

Picking a project team is probably the most crucial task and hardest challenge for a project leader. There is no absolute right/wrong answer when picking a team as individuals have different strengths...

I do believe that the medical device community is progressing towards a global system of regulating medical devices. I think that as more countries get more industrialized and gain more technology, co...

The quality plan is needed for many different reasons. The quality plan document verifies the internal and external standards and procedures. Besides that, the document also provides some insight as t...

Some advantages of the Functional Organization is that the departments operate somewhat independently of each other so coordination between members of a department is much easier because they can only...

The way that I think about a project proposal document is that it is a formal way of persuading the leaders of your company, such as CEOs, managers, and stakeholders, that your project is worth invest...