There a multitude of ways schedule variance can occur within industry. We learned from the lecture that schedule variance is the difference between your earned value and planned value. Generally if yo...

I believe it is important to assess the change from a patient impact point of view. Any small design change can have rather large implications to sterility, packaging, or even biocompatibility. These ...

With my current position I deal with a lot of ECO since the product line I work with was from an acquired company and currently out in the market. The ECO was initiated after staining was observed on ...

I agree that deviations are important to keep included in both validations and verification reports. Deviations can provide important information that ultimately can change the whole output or scope o...

Similar to the posts above, I experienced an issue during my capstone project of missing a milestone. My team was developing an ultrasonic transducer for therapuetic use. Some of the components which ...

It is important to understand the other individuals point of view. There can be a multitude of reasons why the other individual is unresponsive or willing to have sit down meetings. Generally, if you ...

Within my company there was a project I worked on where we looked to have a new titanium bone screw system used with foot for bunionectomies, fractures and osteotomies released. The system was acquire...

Gantt charts provide a nice holistic visual representation of all the tasks within a project and the timeline proposed to be followed. Within those tasks we can see the breakdown of the sub tasks as w...

Project planning as the majority of the posts above indicated is important and overall sets the foundation and path moving forward for the project. The planning phase I do agree that returning to acti...

Within the company I work for, although I am not directly involved within the design review meetings, I have spoken to a couple R&D engineers who partake in these meetings. They describe the cultu...

Ethically speaking, I do not believe any project manager should feel the need to work those under his wing to exhaustion. The overall goal and objectives for the project are set forth in the beginning...

I agree with the majority of the above sentiments. Another important perspective to obtain would be that of the surgeon. Within my company, the R&D engineers work directly with the surgeons on des...

In my experience with suppliers, they are always open to providing suggestions for process monitoring, potential avenues of future risk, and additional cleaning steps to ensure the safety of the produ...

Typically within the medical device company I work in, design changes are generally driven through an engineering change request. These ECRs generally have five phases where phase one is when the over...

I think it would be wise to get everyone familiarized before starting risk management meetings with the ISO 14971 standard. Before even running these risk management meetings it is important that ever...