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 Engineering and currently I am working on my M.S in Mechanical Engineering. So,…   Read more»

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 negotiation can be used in similar cases. So, my company is electromechanical supplier…   Read more»

NDA (nondisclosure agreement) is a legal contract that protests sensitive information. NDA can be used when new product or design is in developing stage to help the inventor keep patent rights. Properly written NDA can help the inventor hold the…   Read more»

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 point. Based on my assumptions the non-welcoming might happen more often in smaller companies…   Read more»

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 project team. I chose it because I will have a lot of more authority…   Read more»

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. Many times we cannot choose who will join our team. If it’s possible we should…   Read more»

Medical device manufacturers cannot depend on procedures to decrease the risk as they used to do in the past. Additionally labeling must be still shown on the medical devices, but it cannot be longer used to mitigate risk. The idea…   Read more»

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 materials to my company. The corrective action gives the other company…   Read more»

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 on the solicitation and doing the basic estimation you can figure out how risky…   Read more»

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 small group of people is tested for couple of months. In…   Read more»

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 manipulations to the device and perhaps replace some components. It is crucial when we want…   Read more»

Hi, I never attended design review meeting. Although it’s very similar with other meetings summarizing activities during a project. It’s very important to meet while the milestones are done to review the situation. During the design review meeting people can…   Read more»

Hello, There are many consequences of the insufficient design control. The design control must contain different stages such user need, design input and design output. User need is important because we need to know what the user expects. For the…   Read more»

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 correct any errors during the product development. Medical devices must meet quality and safety standards….   Read more»

Validation and verification are very similar. Verification is performed to check if the design follows to specifications by verifying the documents and the design. Verification uses different methods such as reviews and inspections. In this case the person checks the…   Read more»