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 de...

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 ...

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...

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

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 si...

I have worked within both divisional: product-based and matrix organization. I would still consider the matrix to be organization structure of choice....

Based on my current work environment, I would say my work organization is a matrix organization. I work within the operations division as manufacture ...

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...

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

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 tea...

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 m...

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 phase...

Hi Roberto, Meeting notes are important with respect to relaying critical information on projects to creating timelines for projects. I know in my ex...

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

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 ...