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. During the project planning phase, you want to ma...

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 planning phase were all of the packaging that...

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 already been explained quite will in the posts abo...

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 giving to much priority (high risk level) to ever...

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 the project after the project has already been init...

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 satisfactory, they will file a complaint. For example,...

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 that the testing that is done is in fact adequate ...

The discussions that we have been having this week around test failures and untested medicine lead me to start thinking about failures in the product that are identified. When a defect is identified f...

The FDA has a program called the Humanitarian Device Exemption (HDE) Program which allows for medical devices intended to benefit patients in treatment or diagnosis of a disease or condition that affe...

The difference between verification and validation is well explained by considering the question that each is trying to answer. Verification answers the question, "Did we make the device right?" while...

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 affected by the outcome of the project. For example, ra...

Currently I am working at a company that has traditionally been structured as a functional organization. Employees work on a project within a department, and report to the manager of that department. ...

In response to krp67: Is there "generic form" that you proposed a suggestion that the regulating body for medical devices should be a global organization? Or is your suggestion that a company's docume...

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' job full of obstacles and headaches in order to ma...

One of the major determinants of the length of a project for a medical device would be whether the goal is to obtain a 510(k) clearance or a PMA. To obtain a 510(k) it is only necessary to demonstrate...