After listening to the lecture, it is clear that it is easier to get devices approved in the EU for several reasons. The EU bases their classification on an essential requirements checklist and on risk. In the United States, regulation…   Read more»

I do not have any experience with working with PMOA for a combination device. After doing research on this topic, I have come to the conclusion that if a company cannot identify a PMOA, a Request for Designation can be…   Read more»

Hi Fady, You made a very excellent point because there is definitely a greater chance of data distortion if too many centers are present. Variability needs to be controlled and in order to do so, the scope of the study…   Read more»

Hi Andrew, Unfortunately, I do not have any experience in this area, but I do agree with Dr. Simon’s lecture on getting in touch directly with the legal department in order to expedite the process of signing contracts. The legal…   Read more»

I do not have any similar experiences to the one you provided, but I can definitely say that it is an interesting one. The situation does in fact violate the NDA or CDA for multiple reasons. The consultant is outwardly…   Read more»

As other students mentioned in their posts, a written agreement is considered a legal binding document, and thus, the agreement is essential if the matter gets taken to court because all parts of the legal contract are clearly stated and…   Read more»

Undoubtedly, this course was incredibly beneficial and a great learning experience. Before enrolling in this course, I did not hear much about the material, and initially expected to learn about the theory behind developing a medical device. Frankly, I was…   Read more»

I would choose to startup the company with a Matrix organization. This type of structure would be the most beneficial because the project manager himself can choose employees from different departments—those who would be the most qualified for the particular…   Read more»

Hello Lamiaa! That is a very interesting question. It would be more challenging for the project manager to work in a Matrix organization. As mentioned in Dr. Simon’s lecture, every member of the staff as two bosses or more, and…   Read more»

Currently, I work in a functional organization structure. In the research and development department, engineers are required to work on a certain project without input from the quality engineers until the time comes. When the project is said to be…   Read more»

Reducing risks “as far as possible” is definitely a huge challenge for manufactures. I believe that the statement implies that not all of the risks can be reduced 100%, but it should be reduced as much as possible in order…   Read more»

Wow, reading this was extremely interesting and a definite eye-opener. It is an interesting discussion. Companies should perform risk assessments throughout the entire lifecycle of the product—even when it is placed on the market. This is a way to ensure…   Read more»

I agree with other students in regards to offering the company a subscription where they can access a database that supplies access to all of the necessary documents. Employees will continually have access to articles while the company as a…   Read more»

In my opinion, it is very difficult to claim one portion of the DDP as the “most important.” However, if I had to choose a certain aspect that is important in the plan, the scope management plan stands out immensely….   Read more»

The last thing a manager or an employee wants to do at a meeting is to take the minutes. However, it is an extremely important and necessary task for multiple reasons. A person’s memory is unreliable and it is useful…   Read more»

Out of all of the stages that a company’s product goes through, design transfer is the most important. In this stage, the design of the product is introduced to production and requires a full evaluation of the product’s design documentation,…   Read more»

Safety is a key factor when designing and developing a medical device. Regulatory bodies, such as the FDA, wants assurance that the medical device is safe before bringing the product to the market. Thus, the essence of Design Controls is…   Read more»