In the lecture this week we discussed both aspects of design controls and project management in the life cycle of a project. It is emphasized that the design controls of the project and project manage...

I think the best project management software ideally would integrate scheduling tools, have some form of traceability, or be able to reference deliverables such as important documents or design files....

Medical device development is reliant on organization and structure in order to produce a successful product. These structured processes can include design reviews, design changes, and the PDCA cycle....

Pulling from my experience as a Resident assistant, a big part of our job as a leader is to deal with conflict resolution or handling certain situations. A big thing that I try to do in these scenario...

In this weeks lecture, we discuss in depth the role of the regulatory department after a project has been completed and is now an available medical device on the market. The regulatory department is r...

I agree with Vansh to some extent in that the Regulatory Affairs Specialist is the team member that more closely works with the FDA and creates the legal strategy when dealing with them. That said, it...

I think the thing that makes the project management role so interesting is that you do not necessarily need to have a deep level of understanding in one particular field or discipline. I find that the...

As we are aware, Biomedical projects are often faced with tight deadlines, regulatory requirements from the FDA, and collaboration amongst different teams with varying backgrounds. In this sense, the ...

Taking away from my personal experience, I think there are several different ways to ensure that communication is properly established amongst a team. Drawing from my experience as an RA, the best com...

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...