A verbal agreement could technically be an oral agreement or a written agreement, so in terms of the difference between the two there is virtually non...

In terms of medical device contracts, the most common way to resolve conflict in contract laws often revolve around negotiations, mediations, and arbi...

Overall, I really enjoyed the course and the content provided to us. Where as capstone showed us more customer oriented elements of medical device dev...

As some have commented, I have not personally had the experience of working in industry and been able to be apart of a project team. However, with tha...

As with most things, I find it is often a balance of both and it not as clear cut as it may seem. Management provides structure to a project and is of...

I think the easiest way to avoid this scenario in this instance having "two bosses" as you put it is to essentially have each boss fill a particular r...

Going based on of the question proposed in the title of this post, Risk assessments are absolutely necessary for medical devices. Risk analysis or ass...

As was already said before me, I think it is virtually impossible to completely eliminate risk. Even using a medical device in perfect conditions and ...

I believe that in most scenarios it is ideal for the risk management team to be made up with members of the project team and those that belong to the ...

To answer your question, I do not believe it possible to entirely predict all real world failures of medical devices. The core problem of design contr...

In reference to the title of the question, I do not think that there should necessarily a winner in regards to whether user needs or engineering viabi...

I believe that you make a great point that the constant updating of the documents contents can become very confusing or lead to an overload of informa...

Teams can establish when they have done enough reviews by following the framework they initially created at the beginning of their design process. To ...

I think that design controls ultimately help innovation because they make the design process more sustainable and efficient in the long run. Checkpoin...