There are typically pre-existing standards for the verification testing. International ISO standards exist to insure that proper function and safety are accomplished. Additionally, for medical devices...

I am also currently doing my senior design project as well. It is clear to see that it simulates the design control process. I would like to add that we have a design review coming up to go over the p...

That is true Roberto. It definitely depends on the product, but I agree that they will all go through the life-cycle. This however can extend over various durations as the product may be difficult to ...

You bring up an important point krp76. Both the instructions and training play a pivotal role in ensuring that Human Factor aspect is well considered. Taking into consideration all aspects at play is ...

From the information I found a significant risk device is one that can present a possibility to affect the health, safety or well-being of an individual. These are often class II or III devices such a...

Hello, There are great points made above. I agree with the aspect of their similarity in terms of being responsible for the completion of projects in a timely manner. Organizing individuals, delegatin...

You bring up a great point Roberto. I would like to add that though many of those in the project management role are good communicators, there is an additional skill that only some have. This skill is...

I believe a majority of project management skills are applicable across the multiple disciplinary fields. These include effective communication, leadership, team management and organizational skills. ...

From my time at Maquet I got the opportunity to work on multiple projects. Though departments were typically split functionally, a majority of the time an individual was assigned to each project. Howe...

You make a great point Juan. Anything valuable in terms of an agreement should be appropriately recorded. Especially in business when valuable ideas, ventures and careers are at stake. Though, as a fe...

I would like to suggest "Medical Device Industry Preparedness" or something similar in terms of preparation for work across a variety of disciplines in the Medical Device or even a more broad Medical...

Hello, I feel our class mates described the difference very well. I would just like to add that at times the idea may not be developed enough to allow for a patent application. In these cases it is ad...

Hi Saad, I agree with your point. However, I think it is more than just the size of the company that decides the best organizational structure. I believe it could vary based on the type of company, in...

I work in a similar environment. I certainly agree that the convenience of have an entire, or a majority, of the department be familiar with the ongoing projects means that if an individual is unavail...

Luisa, You make a great point. In addition I would like to point out that in a matrix organization each staff member has at least 2 bosses, as mentioned in Dr. Simon's lecture. I believe this can add ...