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 was used. Simple…   Read more»

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 above. One…   Read more»

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 every risk, instead of…   Read more»

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 initiated. As a project manager, it is…   Read more»

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, it is possible that the product was…   Read more»

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 for verifying the…   Read more»

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 affects fewer than 8,000 individuals per year. Since conditions…   Read more»

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 validation answers the question, “Did we make the right device?”…   Read more»

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, rather than being tasked with coming…   Read more»

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. However, there is a very open environment and…   Read more»

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 documentation should be formatted in such a way…   Read more»

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 make sure that a new product…   Read more»

As rjs84 said in their response, the company’s highest priority needs to be maximizing profit. If you cannot sell a product, then you will not be able to fund development. With this in mind, a major determinate of project priority…   Read more»

The company that I currently work at is quite proficient with project management. It has a dedicated project management office with several project managers. Projects are ranked in priority, and the status of the highest priority projects are regularly reported…   Read more»

Parth brings up a very good point. Interpersonal skills are not just people skills, they are crucial communication skills that allow you to convey effective ideas to the people that you work with. In an office setting, this can be…   Read more»