The company being told to cease operations goes to show that not following these requirements are more than proof of the consequences, are they not? You’re right in that a company can decide to not follow requirements in attempt to save and money, but eventually they are allows going to get caught. The worst case scenarios for a company not…[Read more]

I believe the simplest remedy to the situation proposed would be to have the project manager hold a meeting with each team member, and ask them how long they think it will take them to complete the project. If the team members completion time is too long then perhaps the project manager could assign a new member to the task. However, we also…[Read more]

It is hard to understand what you fully mean by your question Ryan. To fully grasp the concept of your question I would like to know what you mean by personal connection? The most severe case I could imagine would perhaps be a project leader who needs to move forward on a project that they believe would help a family member. In a less extreme…[Read more]

There are many types of ISO requirements. ISO is an acronym for International Organization for Standardization. The one that Dr. Simon discussed in this weeks lecture refers directly to the application of risk management to medical devices. There are many of these to pick from that I feel are necessary in creating a successful product. ISO 13485…[Read more]

I would have to say that the pros and cons of a single, or separate team would vary dependent upon the project. If it were a small project with low risk then there would be more pros in the favor of a single team that handles both project, and risk management. Class I devices are a good example of a project that would only require one team, as…[Read more]

As many others have stated in this thread, good interpersonal skills are an extremely beneficial trait to possess. However, I do not agree with the statement that it is 70% interpersonal, and 30% knowledge. Interpersonal skills are important because having an idea, but no good way to convey it is comparable to that of having a beautiful voice, but…[Read more]

When dealing with experiment failure I believe it is necessary to take a step back, and reflect on what could have gone wrong. Errors cannot be fixed without first knowing what the problem is. Brainstorming, and working through the process of the experiment theoretically before the performing of the experiment is, in a way, like proof reading a…[Read more]

I did an internship at a project based organization. I enjoyed my time there, and working with the team was a breeze. Project ideas are very easily announced, and discussed about in the workplace. It was a fairly small team so conveying information to one another was extremely simple. As much as I enjoyed it, I think a matrix organization would be…[Read more]

I agree with you that there would be more pros to creating a universal regulation process than there would be cons. In regards to which countries would use these processes, I believe it would have to be something that were added to the United Nations list of goals. One of there goals is ‘good health and well being’; so it would have to be some…[Read more]

During my internship I worked on the Verification process of a product. It was heavily research based, and was in its early stages of testing. I think I would like to stay in the design verification phase for a few years when I graduate and work full time. Eventually, I think I would like to become a part of the planning/design control. The place…[Read more]

I agree that this system is fine as it is. I do not believe that more classes need to be created. As stated before this system runs entirely on risk and safety of the product. In the mini-sim the LAA closure device was considered as a class II because it is a heavily used product and its regards to safety are well known. The original question…[Read more]

I would agree with the participants statements who posted before me. The FDA already has set regulations and guidelines that are established to aid companies with the creation of their devices. Most devices have to go through rigorous testing, and protocols in order to begin being marketed. However, there is always room for improvement! In order…[Read more]

No, not all products require a 510k, but all devices getting a 510k are a medical devices. If the device is something non-invasive, and simple such as that of a band aid, it would be classified as a class I device. Most class I, and few class II devices require 510k’s. However, these devices are still subject to certain more general controls. To…[Read more]

I do not believe that a faulty label on a batch of drugs would cause for an entire recall of the product as that would be extremely expensive for the company. Instead I believe the company would release a large statement explaining what happened this faulty labeled batch, and that anyone who receives their product should double check on the…[Read more]

I do believe that interpersonal skills are valued more heavily than that of technical skills. I say this because when I think of a person going for a job they first need to apply by sending out their list of technical skills, called a resume. Companies can receive thousands of applications for one position. Now let’s say that out of the thousand,…[Read more]

I am not currently employed in industry work as I am heavily focused on completing my school work. Though I have yet to fully immerse myself into the industrial world, I believe I would do well beginning in a functional organization. I believe this would be a good start for me because it would provide guidance, and proper experience from members…[Read more]