This is a really interesting topic to discuss. There are many pros and cons of having a written agreement versus verbal agreement. Many medical devi...

I agree with all of the participants in this post regarding Dr. Simon’s class. This is my second semester as Masters in Biomedical Engineering and al...

This is a really interesting question! In order to successfully complete a project on time, project team must collaborate at a defined frequency and ...

I believe my organization is consider to be Matrix Organization, but also overlaps with the functional organization. We have a CEO, followed by Group...

My company also uses the FMEA (Failure Modes Effects Analysis) technique to evaluate the risk associated with the medical device or production process...

This is an interesting topic for discussion! I agree with Dr. Simon that labeling or putting a warning on the package is not a direct way of mitigatin...

I agree with most of the participants on the above post. ISO 14971, major regulation detailing the Risk Management Requirements for Medical Devices. ...

This is an interesting discussion topic! In the medical device industry, it is very critical to have the most up to date DHF as the project moves for...

I agree with most of the participants in the above posts. During my senior design class at NJIT, I learned more about the requirement and the test me...

I do not have an experience with design review meetings in the industry, but I will share my experience participating in the design review meeting for...

This is an interesting question. I agree with most of the participants that depending on the device classification, EU regulatory looks at the device...