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 none as an oral agreement is a type of verbal agreeme...

In terms of medical device contracts, the most common way to resolve conflict in contract laws often revolve around negotiations, mediations, and arbitration. These processes are not individual proces...

Overall, I really enjoyed the course and the content provided to us. Where as capstone showed us more customer oriented elements of medical device development, I feel as though this class conveyed mor...

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 that said I think that I would ideally like to be in ...

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 often the backbone of the quality and compliance asp...

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 role without stepping on the others feet. For examp...

Going based on of the question proposed in the title of this post, Risk assessments are absolutely necessary for medical devices. Risk analysis or assessments are required not only in the US by the FD...

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 following intended use protocols to a tee, there i...

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 risk management department. The individuals that a...

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 controls is that they are created with what the designe...

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 viability are more important. The teams should instead ...

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 information as you say. The most important thing to do in...

User needs are often qualitative, for example the customer may want the device to be a specific dimension, or may want the device to be easy to clean. Regulatory compliance however demands that Design...

Teams can establish when they have done enough reviews by following the framework they initially created at the beginning of their design process. To ensure success, teams should plan to have a design...

I think that design controls ultimately help innovation because they make the design process more sustainable and efficient in the long run. Checkpoints such as design reviews allows the creator to en...