Having previously worked in the medical device industry I have seen the testing they do on products that have already been tested and approved and I can say it is very intensive. To see that products from other companies are…   Read more»

The risks in a failure during the verification and validation is missing details that will later become a large issue for the engineer or other department that is running the project. Also, not thinking to test an aspect of the…   Read more»

Quality will eventually be one of the largest resources a company has is its ability to be confident that the product is able to perform after distribution. The quality testing will also come under high scrutiny from the FDA. After…   Read more»

I believe that biggest importance with handling a project proposal is to pay strong attention to the details when making the proposal. When details or omitted or forgotten they can become a way larger issue later in the projects development….   Read more»

I believe when deciding the primary mode of action, you should see what is the main function and what is the secondary function. The primary function of the digital pill is to deliver the mental illness medication and the sensor…   Read more»

The idea of transplanting a artificial human organ into another human is clearly a Class III procedure. This would definitely require a tremendous amount of testing and would be strictly regulated by the FDA. This testing would not only take…   Read more»

The new generation of smart watches does make it a slight bit confusing about whether or not they should be considered a medical device. The device does not monitor blood pressure but it does attempt to monitor the wearers heart…   Read more»

The most important thing for me in a group aspect is the ability of the team to communicate and work together. A team that is less talented but able to work together well will normally surpass the team that is…   Read more»

I believe that it is the schools responsibility to teach the technical aspects of the field. I think it is on the student to learn the outside business and social skills needed to succeed in business. Personally, I believe the…   Read more»

My project management skills are from the corporate standpoint and more from the individual projects I have taken on through my personal life. I have handed school projects well and often taken the leadership role for the projects. In my…   Read more»

@Julienneviuya I understand that the spouse does have a good deal of leverage but I have heard that this ca lead to some very uncomfortable situations. As a medical device sales person it is hard to maintain a friendship with…   Read more»

I think I would definitely prefer the matrix organization in every position except for the project manager position. I believe that it is difficult to lead a project when the functional managers are constantly pulling on your employees to do…   Read more»

When it comes to building a project team it is definitely necessary to focus on skills and not personal relationship. I do not believe that it is healthy from work and personal life to overlap too much so to avoid…   Read more»

I believe that personally I would be more fit for the upper management aspect of the procedures. I can better work with multiple groups and be able to reason out a fair schedule for groups to follow. The middle management…   Read more»

One aspect of low severity risk that people need to understand is that no matter what it is going to occur. You try your hardest to avoid these situations with sampling an strong quality establishment but it is never going…   Read more»

I was not aware that you have to pay to view the regulations. I am sure that it does help in the upkeep of the companies that are writing the regulations but I do think this favors innovations from current…   Read more»

Risk management meetings in my opinion are the most successful with a great deal of varying backgrounds. When creating a risk document it is important to encompass all of the possible negative outcomes. For my company they are categorized by…   Read more»

Validation in a way is an abbreviated version of the verification. It will allow the user to guarantee that the device or fixture is still functioning at its necessary caliber. It can begin with something as simple as checking the…   Read more»

As you near the verification process the design review meetings become very important as they are a great opportunity for coworkers, management, or even document control to realize an issue in your verification before it is initiated. Once initiated and…   Read more»

For a verification that I was recently working on we tried very hard to make sure the verification was written in a way that deviation could be avoided. We attempted to run the test ourselves as well as making sure…   Read more»