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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   Read more»