I learned a lot about the medical device industry in this class. At the beginning I was a little scared because I finished my B.S in Chemical Engineer...

I would like to write a story about the out of court dispute resolution which happened in my company. It would give an idea what mistakes and negotiat...

NDA (nondisclosure agreement) is a legal contract that protests sensitive information. NDA can be used when new product or design is in developing sta...

I also haven’t had any experience in a non-welcoming culture myself. I saw a struggle of another Engineer who was shy, quiet and couldn’t make his po...

I would desire to work in a Project-based Organization as a PM. Often; the project manager makes the decisions and has whole control over members of p...

It’s very important to get the right people to perform good project team. We need to evaluate the professional performance as well as human qualities....

Medical device manufacturers cannot depend on procedures to decrease the risk as they used to do in the past. Additionally labeling must be still show...

The CAR (corrective action) would be a good method to manage the risks. I had a chance to send few of them to the vendors when they send defected mate...

Currently I work in the company which supplies US Army with mechanical equipment. Some portion of my job is to look for the solicitation. By looking ...

Hi, During the phase I clinical trials we can find out if the drug or medical device is safe to for people. In this initial phase of clinical trials s...

Hi, It’s very important to do the human factors evaluation. It shows the interactions between the device and the user. It’s performed to make some ma...

Hi, I never attended design review meeting. Although it’s very similar with other meetings summarizing activities during a project. It’s very importa...

Hello, There are many consequences of the insufficient design control. The design control must contain different stages such user need, design input ...

Design Control is a set of management practices such as procedures, processes and policies. They have to be followed to ensure proper quality and to c...

Validation and verification are very similar. Verification is performed to check if the design follows to specifications by verifying the documents a...