There is definitely a difference between verbal agreement and written agreement. Verbal agreements don’t seem very solid, and can be manipulated if there isn’t proof of the agreement. Written agreements seem a bit more trusting, since there is physical proof,…   Read more»

I agree with the fact that if there is a business deal between two people, it shouldn’t involve other family members. Therefore, I don’t think that the restrictions are too much. Because its a dinner to discuss projects, it should…   Read more»

Dr. Simon, I learned a lot from this course, and I think I have a better outlook on what to expect in terms of going into the industry. I haven’t had any experience in the industry yet, and before taking…   Read more»

I also agree with Adrian. If there is a set up for a collaboration, the organizational structure shouldn’t matter, but more so that the companies are working together and being efficient. However, companies individually can decide how they want to…   Read more»

I think its best to work with people who are more knowledgeable in their area, than with people you are close to. I think its a bad idea to work with people you are close to just in case something…   Read more»

I do not currently work in an organization, but if I had to pick the type it would be a matrix organization. I like that with this type of organization you can transfer knowledge about the project with other departments…   Read more»

First, I’d want to make sure that everyone in the project understands what the device is, its purpose, its design, and how it will be processed. Once we understand the device and what is going to happen, we can then…   Read more»

one factor to consider is the assessment of the risks of the device. With this assessment you can determine the severity and number of harmful events associated with this device. Also, the probability of harmful events, duration, and the risk…   Read more»

Risk Management is required by the ISO 14971, and must be completed by the company. The company will go through the cycle of assessing, evaluating, managing, and then measuring the risks. The company is responsible for taking all aspects of…   Read more»

I think a successful validation process involves repetition and numerous trials of testing. I haven’t had experience in the industry with medical devices, but I have done research where we were required to do experiments and make sure that our…   Read more»

Everyone raised some good points regarding verification and its importance. Verification is indeed an essential process in design control, and it can also aid in risk analysis. By verifying every aspect of a medical device (dimension, function, biocompatibility, life expectancy),…   Read more»

I also had to complete Requirement Documents and Test Plans for my capstone senior project. I agree that it does take a lot of time to complete because of the major details that are involved. However, these documents are definitely…   Read more»

I’d also like to add on the importance of risk analysis for a Design Control System. Overall, everything boils down to the well-being of the people, and that is why the FDA needs to ensure that the product performs as…   Read more»

I also agree, the DHF documents should always be updated throughout the project. I have not had experience dealing with DHF files but based on what I have learned so far, I think that updating these documents frequently will be…   Read more»

I guess it depends on what role you decide to pursue. When it comes to clinical studies where it involves dealing with patients, then I think a clinical background may be necessary. Dealing with different types of people isn’t always…   Read more»

One product that is very popular today are GoPro cameras. They do not use television to advertise their product but instead they have used youtube. However, they did not directly advertise their product but instead you see people using the…   Read more»

A vision statement is what the company wants to accomplish and the mission statement is how the company does its business. I think that these statements are important for a company to have because it represents what they intend to…   Read more»

I agree that social media has become a popular way of advertising in today’s society. There is also the idea where sellers involve the customers in the product production/improvement. Sellers of products now allow customers to send them comments on…   Read more»

I think it all depends on the type of business you would like to pursue. For instance, if I wanted to pursue a company that produced medical devices, I’d want to have ownership of a C-Corp. With medical devices, you’d…   Read more»

In order for the court to pierce the corporate veil, there must have been an unlawful situation within the corporation. For instance, if the corporations assets have been used for personal finances as opposed to using it just for the…   Read more»