I think FDA wants to know if the medical device companies are following the Design Control procedure and have valid design control procedure. They need to make sure that this companies have valid protocols they are following, because the main purpose of this is to know that this devices won’t harm anyone. They are as follows: planning, input and…[Read more]

I agree with what you have to say about the design verification. It is absolutely necessary to verify design before it goes out for production, because as an industry if you miss even a small thing, it would end up costing you millions, if not billions to repair the fault. If the device is harmful it will hurt the company even more, because they…[Read more]

Again, I don’t have any experience on making gantt chart for a company, but I have made gantt chart for my capstone class. I think the first thing to do is the set up the start date and the end date of the project. After that, you should find out what the critical tasks are. When making the gantt chart, give as much time as possible for each…[Read more]

I have been to few meetings, where minutes are taken, this are really important especially if you are forgetful or busy in general, because you can always look back at it to know what happened in the meeting. The main reason for this is, because lots of tasks are assigned during the meetings. People have finish this task by given deadline. This…[Read more]

I did some research on FDA website for this class and before in capstone class and the one thing I found out is that FDA doesn’t care what type of tests you perform as long as you consider all possible tests and perform them. I think it makes sense because as you mentioned it, every product should have different test because of their biology,…[Read more]

I think it should go like this:
1) Hazards that fall into a low severity risk, are considered generally
acceptable and will not require further analysis.
2) The one with the medium severity should be looked over and find the problem and mitigate it.
3) Hazards that fall into a high severity risk, are generally unacceptable. If
hazards at these…[Read more]

I think as far as possible, is what is literally should be, because the human life is worth more than anything. We shouldn’t worry too much about cost of making product because people will pay more money with higher qualities than pay less for a product that could be harmful for you. It will also end up costing you too much money if you get…[Read more]

I would prefer to be clinical quality assurance, because it gives me chance to go over complete process. It also helps me find different process or find different issues that the whole clinical process could have. Another process I would prefer is being principal investigator, because it will give me a chance to look over the study and help the…[Read more]

One biggest product I have seen is motors used in Dr. Foulds labs. I haven’t seen them on any advertisements on tv or internet. The way I found out about their product is because they sent a sample motor to Dr. Foulds lab as an advertisement. After see that motor, Dr. Adamovich bought similar motor for his research. Another example, I think is…[Read more]

It’s actually simple. Vision is what do you dream your company to be in the future, while mission things that applies to their customers and works. Ex: johnson and johnson their vision to make helthcare system better, while their mission is Caring for the world, one person at a time.

I think comparing apple products with me medical device products is a bit of injustice. Apple products in general are made for everyone while medical devices are made for only select group of people such as doctors, patients etc. Apple tries to make their products as cheap as they can while still maintaining profit. While the medical devices are…[Read more]

I would prefer being a partner in a corporation where I hold certain percents of their shares. Because at least that way I don’t have to worry about losing my money while working in a company. I think its too much tension when you have to worry about making money through solary and also worry about your company.

As I mentioned in previous post, I think there is more room for growth in private and small company because the company itself is growing and you grow with it. You learn to become a leader, because you need to finish certain projects while being on budget and not having a resources. While in corporation, your job is mostly safe because the company…[Read more]

Personally, If I had a similar type of job offer from two different companies, one is a start up and the other is a big corporation and if they both paid me similar amount of money. I would choose the start up, because there is a lot more room for growth and become a leader in a startup then in corporation which is already at its height. But at…[Read more]

I don’t really have any experience with company and what goes on in the company, but from what I learned from the slides and the lecture video, I think the biggest arguments that the Quality Engineers have is with R&D department. It could potentially be with every other departments as well, because they are basically in charge of making sure that…[Read more]

Making sure that both the R&D and quality engineers do their jobs would make it extremely easy improve a document. Besides that, the improvements comes with time. As Dr. Simon mentioned in the presentation, as the company grows in the size more rules needs to followed and thus more quality engineers are needed.

In general, the quality is one of the most important part of the company and that is the main reason why jobs for quality engineers are in demand. The best example that related to quality in general is the Ford Pinto case, in which the company decided to not include fuel system modification because it cost extra $11 per car, ultimately saving…[Read more]

They are both important to the FDA, because these are the numbers that decide if the device is going to work and how well will it work. For example, if you are inventing a device for chemotherapy it is must to know if the machine is accurate and precise. Because if either one is bad and the FDA cannot pass the device because device could harm or…[Read more]

I think it is fine that US is doing that and the only reason is because it is really easy to get things passed in countries like India. From experience, as long as you pay people money there, you can get bills, laws or devices pass. In addition, US is also leading medical device countries and that’s most likely because of its FDA regulations.

Yes, the rules are hard and its even harder to go through the process of getting your product pass. However, I believe it is necessary to keep it this way so that big companies don’t take advantage of the process and ruin its patients lives. The research might be delayed because of this but I personally think it is necessary to have this rules.