If I had the opportunity to build my own project team, my first focus would be on what group members would do based on their skills to create a multi-functional dynamic. Being able to utilize each other’s characteristics in different…   Read more»

To start, I think all of the organizational structures are effective, and what determines if the style is “best” or not is dependent on the medical device company. I really like the matrix organizational structure out of all of them,…   Read more»

I am currently employed at a public middle school, which is considered a functional organization. Like most functional organizations, the resources are controlled and authorized by the functional managers and project management is considered a part-time responsibility. In the future…   Read more»

From what I have read a standard risk management plan consists of five factors: definitions, presumptions, detailed structure of risk breakdown, impact, and cost. Definitions help with clarification on identifying potential risks, presumptions are planning ahead of time for potential…   Read more»

The mistakes that medical device companies have been making have been unfortunate to see. I believe these issues concerning risk management seem to be a pattern among companies. I have to agree with most of the posts above, analyzing the…   Read more»

Working at a bakery was a unique experience that came with risks that I was unaware of prior to starting. Health was always a first priority, risks can come from cross contamination and foodborne illness. To prevent these risks, the…   Read more»

As stated at the start of the discussion, the main difference between the two is the needs that must be met. Verification focuses on confirming if the design output meets the design inputs and validating that the design has its…   Read more»

So many great points on why Design Control is important to have been shared. Simply put, Design Control assists with the assurance of the safety and effectiveness of medical devices. When there are issues concerning the quality system, investigators look…   Read more»

The dialogue under this post has shared a lot of great information. One of the most effective ways I believe researchers can try to make sure the placebo effect does not interfere with the results is by double-blind study method….   Read more»

There are many benefits to a double-blind study, but I believe the top reason is that this form of study ensures less chance of bias. Double-blind studies can also allow researchers to follow the same protocols and administer the same…   Read more»

This is a great question and the discussion for this post has been very insightful. As mentioned, Clinicaltrials.gov is a great resource to find clinical trial results. Do you all believe that a universal data base should be created and…   Read more»

I have noticed that companies that are geared towards health benefits or that promote healthy living use the color green. The color green represents many things such as nature, wealth, and health. Companies like Whole Foods Market, Sprouts Market, and…   Read more»

I have noticed that companies that are geared towards health benefits or that promote healthy living use the color green. The color green represents many things such as nature, wealth, and health. Companies like Whole Foods Market, Sprouts Market, and…   Read more»

Public and private companies share many similarities and differences but are both necessary to exist. Public companies have more reporting requirements than private. They must routinely issue financial statements that reveal the current state of the company’s wellbeing. With private…   Read more»

I agree a lot with what was said under this post, and being able to see the different perspectives for each was insightful. I think a limited liability partnership is what I would be interested in based on the limited…   Read more»

I agree with most of the posts on this specific topic, the FDA is well within reason for their guidelines because, while there are other organizations that protect public safety. There are many necessary things that the FDA ensures for…   Read more»

MDSAP stands for the Medical Device Single Audit Program and it is for the conduct of a single regulatory audit of a medical device manufacturer’s QMS that satisfies the requirements of multiple regulatory jurisdictions. The dialogue in this post has…   Read more»

A role that is available in quality management systems is a quality assurance test engineer. A quality assurance engineer identifies errors within the software using a test before a product is set to launch. The primary responsibility of a quality…   Read more»

I believe it is more important to start research that future generations can help carry out. I can understand wanting my findings in my research to be put to use right away but knowing the uncertainty that comes with experimenting…   Read more»

Responsibility for minimizing the risk of suffering and improving animal welfare is what I deem most important in research. I understand that research has to be done to make advancements within many factors of life but I do not believe…   Read more»