When finalizing a consulting agreement, several key elements must be meticulously addressed to ensure clarity, safeguard the company’s interests, and establish mutual expectations. Defining the scope ...

While I don’t have personal experience with consulting, I believe it’s a strong option for recent graduates, especially in industries where full-time positions are highly competitive and difficult to ...

The discussion on verbal contracts is indeed fascinating, especially in the medical device industry, where precise documentation and regulatory compliance are critical for success. While written contr...

Given the structure that was presented to us during class, I would say that my group originally started off as a functional organization. As organized by Dr. Simon, each student was grouped into an ar...

A functional organization is hierarchal structure in which employees are grouped in departments based on their specialized functions or area of expertise. In this type of organization, authority and d...

When it comes to the appropriateness of a matrix type (strong, weak, or balanced) for a medical device project team, it is important to consider several factors, including the complexity and regulator...

As someone who lacks industry experience it is very interesting to see everyone's experience with risk management and which circumstances they encountered with each method (risk avoidance, mitigation,...

Just as many have said above, it is clear that risk management is a crucial process conducted throughout each stage and area of the project, but I would argue that the product design stage requires th...

Risk acceptance is a risk management strategy in which an organization consciously decides to accept a risk without taking proactive steps to avoid or mitigate it. Therefore, to answer the question ab...

The responses seen above do a great job in explaining and describing the steps/process a team must take to define success criteria, but it is also important to highlight the disadvantages that come wi...

This an interesting topic because there are so many medical devices that the 3 categories of design input requirements can be very different. The device that I will be mentioning is a pacemaker, which...

As many of the previous responses have stated, a project proposal is crucial because it establishes the foundation and direction of the project within a company. Not only does a project proposal clear...

When it comes to medical device companies and "corporate responsibility", they tend to the take the matter very serious due to ethical obligations and regulatory requirements. To start with regulatory...

While it is certainly worth arguing that a Design Matrix with the four columns listed above (inputs, specifications, validation, and verification) can provide enough critical information to complete a...

For my capstone project, my team and I designed and developed a mechano-myography (MMG) armband that was able to track the mechanical vibrations of the upper arm while also measuring the changes in ci...