This is an interesting article. It also points out that a medical device is actually faster and less expensive than a medicinal product. But if the co...
I agree with previous posts in regards to NB-MED Guidance Documents being one of the most useful documents. Since it is written by the notified bodies...
I do agree that the EU has an easier system to approve the medical devices than the FDA approval. Initially all the countries in Europe had their resp...
Hello Andrew, I actually do work in a space that deals contracts do perform either research tasks or even with the later stages of the clinical trial...
I personally have no experience working with PMOA for combination devices. But the best way to understand what is the PMOA is by seeign the two possib...
Fady, I do agree with your statement that with multi-center studies, there is a greater chance for variability within the studies. In order to reduce...
Dr. Simon, As most have mentioned above, what is really great about these courses is how it provides a glimpse of student with no work experience with...
Fady, This is a great discussion point. From the example you provided, it is definitely violating the NDA or CDA agreement that the consultant and pr...
Roberto, Fady provides a great example. In my case, whenever dealing with business meetings, it is only the person that is part of the project itself...
My current work environment is a matrix organization. Within the procurement department, I have had the opportunity to be involved in different projec...
It is interesting that in my line of work, there are times that teams are formed due to what projects the team members were involved. And using that e...
That is an interesting question Lamiaa. I believe that for a Matrix Organization, even though it is ideal, could pose more challenges to a project man...
Risk cannot always be eliminated by design solutions. This is why medical devices use protective measures (i.e., – alarms) and inform users of residua...
I agree with the comments above. The acceptance leads to a high severity of risk due to the company not any additional steps to deal with the risk. As...
This is an interesting discussion. The main one that I believe is overlooked is the lifecycle process of risk management. Most companies, as expressed...