This link definitely provides a great representation of the difference between the two. Some key aspects of the DHF that are mentioned are that all the activities during the design and development process should be properly collected and should be…   Read more»

I agree with the comments above that an SOP is a step by step process that provides guidance to the person reading the procedures. In addition, the type of detail that goes into the SOP is crucial to accommodate any…   Read more»

I definitely agree with the QMS system in a small company can start off with various obstacles. But in a sense, it is a necessary rite of passage to get the base standards in place. The tough part is beginning…   Read more»

As mentioned above and within Dr. Simon’s video, the ECO is required when the design controls are finished and the device needs a change. With this, it may create more modifications within the regulatory aspect such as SOP changes, additional…   Read more»

I agree with the comments provided so far. The importance of post-market surveillance is to provide the necessary information on the product being used by patients and confirming that is maintaining the safety and efficacy of the product. Also, it…   Read more»

This is an interesting question. In my opinion, it may depend on the type of changed specifications and how that may affect the device. If it is a change in a minor detail of the aesthetics of the device, it…   Read more»

The verification is when the tests are created for each specification in the DSD to confirm that the design input equals the design output. For instance, if the device is design to be coated black and it was incorrectly coated,…   Read more»

I would agree that the DHF is considered a living document due to its importance in holding all the required information during the design controls. However, after the design transfer process is completed, the DHF should be utilized as a…   Read more»

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 medicinal component, that it is…   Read more»

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 authority to assess and verify…   Read more»

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 individual rights for…   Read more»

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 especially if it deals…   Read more»

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 through the FDA process…   Read more»

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 internal staff throughout the study with proper…   Read more»

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 aspects to expect in…   Read more»

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 company’s name, they are also indirectly exposing…   Read more»

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 the industry, these are aspects…   Read more»

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 J&J in the medical device and pharma sector. It is an…   Read more»

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 of projects. And that…   Read more»

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 resources that sometimes need to…   Read more»