I do not believe that a Non Disclosure Agreement is a substitute for a patent. A patent protects your product from being copied for a certain amount o...

I do not work in the medical device industry and this was the first time I have heard of such a clause. I looked it up to do some more research on it ...

This captures my sentiment exactly. I definitely was expecting something else when I first enrolled in this course. Despite us covering many different...

I believe there should be a balance in order to ensure that all the work which needs to get done, gets done. On the other hand you do not want to crea...

Personally I seem to like the idea of a Project Based Organization structure. To answer your question on which type of medical device company would be...

The formation of a project team is an important factor to consider. There is a balance of selecting someone who is not only qualified for the position...

This brings up a fair point. There is only so much a company can do to reduce the risk to their consumers. At the end of the day, there is not going t...

When designing a risk matrix you can categorize the severity of risk and, thus take appropriate preventative action against each case. If you follow a...

Risk management is an important preventative action that one can take early on to avoid confusion as well as provide clarity to terms of a sort of gui...

As Ridmehta, mentioned most major projects will come with some surprises. It may be impossible to map out perfectly when each segment a project will b...

Hi Hodafattel, I do not work in the industry, however, I can elaborate on each of the two terms which you have mentioned. Validation is quite importan...

As someone whose background comes from Mechanical Engineering, I agree that this is good practice not just for designing a medical device, but any dev...

An instance were I had to create a Gantt chart for the project which I was working on was actually my first time doing so. I think the key when creati...

While the regulations for medical device documentation between the US and EU vary, there are still some basic qualifications every company must submit...