The risk of not meeting the planned dates, particularly the Late Finish (LF) date, can be mitigated by including some buffer time, as smk45 suggested....

I was working on a project to requalify all of the components that were used for a cardiopulmonary device, and one of the tasks that was overlooked in...

The obvious benefits of a Gantt chart and their utility as a project management tool to map out who is doing what and when will they be doing it have ...

I am curious about what is meant by "death by prioritizing and analysis". The way that I understand this is that it is the issue of over-analyzing and...

Scope Management is also important because of the delays that can be caused by scope creep. Scope creep is the continuous and uncontrolled growth of t...

Another source to use to identify risks is with complaint analysis. When your product reaches a customer and the product that they receive is not sati...

The concerns that have been brought up in this thread make a good argument for the importance of test method validation. It is important to make sure ...

The FDA has a program called the Humanitarian Device Exemption (HDE) Program which allows for medical devices intended to benefit patients in treatmen...

The difference between verification and validation is well explained by considering the question that each is trying to answer. Verification answers t...

In addition to the project team, stakeholders within the company also include people who are not working directly on the project but who will be affec...

Currently I am working at a company that has traditionally been structured as a functional organization. Employees work on a project within a departme...

In response to krp67: Is there "generic form" that you proposed a suggestion that the regulating body for medical devices should be a global organizat...

As has already been stated in the posts above, Regulatory Compliance is a tedious, expensive, and lengthy task which can prove to make the engineers' ...