Hi All, I am currently working at Ethicon within Operations. As some of you may know or if you don't know Ethicon is known for developing surgical devices or materials. One such device that they are w...

As a lot of people mentioned before, the biggest different is mainly documentation. A written contract is easier to dispute in court when compared to an oral contract. Often times, what is said can be...

Hi Roberto, In my opinion, I don’t think its too restrictive, you want to keep business within business, particularly with physicians, you don’t want to introduce bias to what your selling or attempt ...

As everyone above mentioned, this course really showed me how the medical device industry works, especially since I just started working within the medical device industry; this course proved to be a ...

Hi Lamiaa, In my opinion working for in a matrix organization is more difficult for the project manager, due to the fact that cross functional team situation, such as sharing resources and staff. Oft...

I have worked within both divisional: product-based and matrix organization. I would still consider the matrix to be organization structure of choice.In my experience within product-based, there were ...

Based on my current work environment, I would say my work organization is a matrix organization. I work within the operations division as manufacture engineer, so I closely work with multiple groups a...

I do agree with the comment above, how severe a failure is by looking at the nature of the harm is a very important aspect. In addition, other factors that may potentially determine risk would be: 1) ...

With respect to medical devices that are used during surgery, lab technicians should be properly trained in aseptic technique, and both surgeons and lab technicians should be aware of how there device...

I haven’t had formal experience with risk analysis, but from what I understand of the risk methodology is that it incorporate all cross functional teams within the products development. Whether if it’...

I have never actually been involved in a design review meeting, but I know from my experience within R&D and now in manufacturing. To me meeting minutes are essential with regards to project deadl...

Hi Lamiaa, If design controls are not adequately used often time the concluding result would be the termination of the project if it’s in early phases or if it’s an approved project this could lead to...

Hi Roberto, Meeting notes are important with respect to relaying critical information on projects to creating timelines for projects. I know in my experience, during these meeting we update the team o...

As many have mentioned before verification and validation often come hand in hand, and they sometimes are used interchangeable, but they are different. Combined verification and validation of engineer...

Design controls are required by the FDA and are implemented to ensure traceability on released products. The idea is that if the released product has a defect which interferes with its function and ef...