I believe that the only responsibility that the sponsor cannot outsource to any CRO is the overall responsibility of the clinical study. I think that any adverse events, injuries and risks will be the...

Hi All, I believe that all of you have touched upon very valuable points. I would like to emphasize that pre-clinical trials (animal trials) are not a safety indicator for many devices. For example, ...

As everyone have mentioned, These simulations are a very useful tool to mimic what usually occurs in the industry. Although I sometimes think that they only scratch the surface of what actually occurs...

All clinical studies for medical devices are conducted with the best intention to benefit humans. Based on this week's lecture, Dr. Simon mentioned that each subject should be informed with a consent...

Through this week's lecture, we learned more about clinical studies and their setup. One of the major points of considerations during clinical trial design is the location of where the study will be c...

Hi Neb2, From my experience, you might have two functionally similar devices but they may have different risks. For example, an infusion pump that is used for normal IV infusion may be considered a no...

Based on this week's lecture, Management responsibility includes the requirement that management should provide adequate resources to achieve a fully functioning quality management system. With our cu...

Non-conforming materials is a very common issue that almost all manufacturers deal with on daily bases. it ranges from regular suppliers to product coming out of the line that does not meet specificat...

This week, Dr. Simon highlighted the importance of quality audits and especially internal audits. The FDA expects each organization to conduct at least one internal audit per calendar year. Internal a...

Hi All, Yes, I agree that the ambiguity of GMPs makes it difficult for startup organizations to find the right way to implement them. When I worked in a small organization, We always struggled to unde...

Hi All, This is a very interesting discussion so far. I want to look at this situation from a different prospective. If I am a manufacturer that is looking to buy some parts or equipment from a suppli...

Hi All, This situation is usually handled on a case by case basis. In some cases, when the regulation is changed or updated, guidance documents are issued to explain the timeframe of implementation an...

This is a great question, and I am currently experiencing that in my current position. Most of the time, projects that are given the GO decision are executed till commercialization. Most of these proj...

I agree with all the aforementioned comments that all these roles are crucial for a product manager. The one point that I have to elaborate on is the ability of the product manager to understand the f...

I have had the privilage to lead the root cause investigations on two recalls in the market. The first recall was regarding a mislabeled lot of product. The lot was inadvertently labeled as a differen...