How does a company decides how much information is to be disclosed via the NDA agreement? What decision factors and criteria are taken into the consideration by the management team of the company? Pl...

This is a really interesting topic to discuss. There are many pros and cons of having a written agreement versus verbal agreement. Many medical device companies execute a supplier quality agreement ...

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 also second time taking a class with Dr. Simon. Pre...

One of the type of organization we learned this week is called the Matrix Organization. There are project managers as well as the direct hiring manager working towards the same goal of the project. ...

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

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

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

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 mitigating risk. There are Instructions for use, also know...

I agree with most of the participants on the above post. ISO 14971, major regulation detailing the Risk Management Requirements for Medical Devices. Medical device manufacturers must have a good und...

In the medical device industry, there are various audits that takes place. For example, customer audit, notified body audit from FDA or BSI, and internal audit. If you participated in an audit, brie...

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 forward with different phases. Many medical device c...

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 method documents and its importance. My professor c...

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 my senior design project. A couple of weeks befo...

From this week lecture, we learned what is Design Control and the different phases of Design Control. Please share an experience working with design control in a school project or in an industry. Wh...

This is an interesting question. I agree with most of the participants that depending on the device classification, EU regulatory looks at the device development in the Tech File. While, in the US, ...