I believe these 4 categories are in the correct position. However, it sounds like you are speaking about a lack of harmonization between all the categories.I think it is very important that there is h...

Participation is a key element of my company's marketing strategy. Our marketing department spends a lot of time interacting with our customers, trying to bring that personal connection that will make...

In my company, typically for testing our implants we follow an FDA guidance document that details the recommended tests for that type of device, and we submit this test data with our 510k submissions....

I had to sign a non compete agreement when I started my job but I have not changed jobs yet so I can't speak to this. However, one of my colleagues is going through this. He recently came over to us f...

I just want to emphasize the fact that companies take these gift policies very seriously. For example, in my company every employee is required to complete yearly training on the AdvaMed Code of Ethic...

I really enjoyed this course, and I think the best part of this course is that it really gives students a very good idea about what the real world is like working in the medical device industry. Since...

I agree with many of the posts above regarding the benefits of matrix organizations. I think this is the structure that I would choose. To reinforce what was already mentioned, I believe that this is ...

My company has a matrix organizational structure, and I would say that for the most part, it works really well and is an efficient way of running a project. One downside which Dr. Simon mentioned is t...

The organizational structure of the company that I work for is most similar to the matrix organizational structure that was discussed in the lecture this week. I have definitely seen the silo effect i...

My company uses many of the tools mentioned above to identify and manage risk. As the professor also mentioned, risk can be associated with the design as well as the manufacturing of the device. Risk ...

Another factor to consider when making benefit-risk determination suggested by FDA in this guidance document is whether the device is a novel technology addressing an unmet medical need. This means th...

I also work as an R&D engineer for a medical device company, and one thing I have noticed in my company is a lack of brainstorming to identify potential risks. I have found that many times our QA ...

Just to add to what was mentioned by several people, they mentioned doing design verification early and often. However, design verification cannot be performed until the design is frozen, which does n...

As Prof. Simon mentioned in his lecture, the validation process consists of design validation and process validation. In a design validation, you assess whether the product meets all of the user needs...

For orthopedic devices, such as spinal implants, knee implants, and hip implants, the verification protocols are usually defined by ASTM standards which govern how these devices must be tested. For ea...