Hi neb2 from the research i did from this week lecture i found few examples that might help you, there is a lot of them but im just going to provide some of them.

for NSR;
-Digital Mammography [Note: an IDE is required when safety and effectiveness data are collected which will be submitted in support of a marketing…[Read more]

Pros to internal audits

When an internal audit is performed you can be sure that a proper accounting system is going to be introduced into your company. If you have never worked in an accounting office or seen what goes on in there then you will not appreciate the fact that if things are set up wrong, everything can go wrong. There is a huge need…[Read more]

Pros to internal audits

When an internal audit is performed you can be sure that a proper accounting system is going to be introduced into your company. If you have never worked in an accounting office or seen what goes on in there then you will not appreciate the fact that if things are set up wrong, everything can go wrong. There is a huge need…[Read more]

It is true that for startup companies not having preexisting GMP as a foundation it will cause a lot of problem, like everyone has mention in this post. What we need to look at here is that even though it would be hard since GMP are like framework with general requirements, maybe if startup companies would try to get some of the GMP from other…[Read more]

hi neb2 very good question i was thinking about this when i was looking at Dr. Simon lecture, what i believe is that a process approach is a management strategy, where a managers is able to control and manage the process that makes up their organization, when process approach is applied to quality system, it means that they manage processes and…[Read more]

GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently…[Read more]

Hi luisa thank you so much for your input yes it seem like it wasnt the same but now i can do see the difference, because what i was thinking i guess it was different thank you for the clarification. This allow me to have a better understanding, and it seem that many people do commit this same mistake.

Hi luisa thank you so much for your input yes it seem lile itneas the same but now i can do see the difference, because what i was thinking i guess it was different thank you for the clarification.

Hi jnm22 thats very interesting anf very scary, because it could affect many of their customers and maybethe company might get sue to some tragic, so do you know how they were able to fix or how they found out about this problem and how long they tool to fix this issue?

I agree with both interpersonal skills and business skills because this will help to either fix or make a good deal with someone you are dealing. So yes you kind need both of this skills at the same level, they should weight the same.

I believe that the most expensive is Introduction Stage, because the company is launching a new product. Further, the size of market for the product is initially low and thus sales are low. Costs of research and development, testing, and marketing needed to launch the product can be very high. In the Growth Stage is characterized by strong…[Read more]

I haven’t had no experience in product failures but I can figure out ideas that how a product can fail. I believe that having a poor budgeting could make a product fail, sometime teams look at different ideas, or plan almost everything, and forget that a major part is expenses, also sometimes not all the expenses are taken into account and p…[Read more]

Hi everyone,

When i graduate from my undergrad i was really lost on what career path i wanted to follow so i decided to do my master and maybe try to learn more and maybe figure out by than which career path i wanted to take. I decided to take Medical device part 1 since my adviser said you would learn technical experience instead of theoretical,…[Read more]

Unfortunately I haven’t experience with this type of documentation in the industry since i do not work yet for a medical device company that would allow me to see or do this type of documentation, so the only experience I have been exposed to technical writing is on my undergrad on my capstone class, and I think as a BME we do a lot of technical w…[Read more]

Hi Fady,

I have to agree with chris vasquez, there is no need to revalidating something that is not being move. what is important here is understand what went wrong with me machine it seem that some components of the machine probably burn out that is causing maybe this failure, which it shouldn’t happen since this machine will have maintenance…[Read more]