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 combination product has both a medical device and a ...

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, it is very useful that they do have the authorit...

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 respective rules and they all had to give up their ind...

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 trials and it is tough to get a contract pushed especial...

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 possible designation. And then evaluate if it were to go...

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 variability, it is important to have the same inte...

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 a preview of what are some of the engineering asp...

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 previous company. Not only are they disclosing that c...

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 would be eligible to receive the set gifts. Within...

My current work environment is a matrix organization. Within the procurement department, I have had the opportunity to be involved in different projects and collaborate with different SME’s throughout...

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 experience that can be leveraged for another style ...

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 manager. One of the main reasons is due to sharing re...

Risk cannot always be eliminated by design solutions. This is why medical devices use protective measures (i.e., – alarms) and inform users of residual risks (i.e., – warnings and contraindications in...

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 Dr. Simon has mentioned, sometimes it is cheaper ...

This is an interesting discussion. The main one that I believe is overlooked is the lifecycle process of risk management. Most companies, as expressed by article, only work with this portion during pr...