Posted by: @orleron Well, you did it! You made it to the end of Medical Device Development. The original intent of this course was to teach you what professionals in the medical device field do in th...

Posted by: @savery115 A small part of the lecture reviewed Upper Management vs Middle Management. Upper Management people are strategic and tend to set the groundwork and vision for what the company ...

I felt most drawn to the matrix organization. The reason I like that format is because it is more collaborative in nature than the functional and project-based methods. I am always inclined to believe...

Posted by: @dparekh Creating a list of risk is a good starting point, however, it is not enough on itself. You also need an action plan for each risk in order to be able to manage them effectively.We...

Posted by: @lmathis When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting? Some risks must be accepted when considering ...

Posted by: @hg93 Risk management is the process of analyzing, identifying and responding to risk factors throughout the course of the project. Managing risks early on in the project is the best way t...

Consider the Design Controls lecture that Dr. Simon has made available. Yes, we know that all parts work together to support the goal of medical device development. What aspect of Design Controls do...

Posted by: @hg93 “Design Controls” is a FDA term and defined in FDA 21 CFR 820.30. Design Controls are an integrated set of management practices (policies, processes and procedures) which are applied...

Posted by: @rgp29 Hello everyone, I have noticed how Dr. Simon keeps pointing out to importance of taking minutes in all the meeting of the team. I never really thought of how important they are. Bef...

Posted by: @orleron As you interact with the CRA profession, you will notice a heavy preference for people with a "clinical background". This means people who have been or are nurses, doctors, or oth...

Posted by: @amandaally1029 With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essen...

Posted by: @dh239 I feel that it is acceptable to take the risk of a clinical trial when the results of the trial are expected to either benefit or not affect those involved. This would be in the cas...

Posted by: @llefevre It is estimated that globally, the market for Clinical Trials is in upwards of $44 Billion as of 2020 and is expected to grow by approx 6% over the next 7 years, mostly fueled by...

Posted by: @amandaally1029 What is the difference between public and private companies? Based on their differences, what are some pros and cons of each? Give an example of a private and public compan...

Posted by: @sahitya-sadineni After watching the videos from this week's lecture, we have learned about the various company types. While thinking about this, would you consider turning down a position...