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 is crucial to take into consideration the different requirements of the various regions such as US,…[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 is crucial to take into consideration the different requirements of the various regions such as US,…[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 can just require only the regression test on that one changed specification. But if the change involve a major part or function of the device…[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, it is already failing one of the verification tests. Design validation is when the design output or the device completed…[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, it is already failing one of the verification tests. Design validation is when the design output or the device completed…[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 reference document to demonstrate the required production specifications. Some of these include how to test the…[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 reference document to demonstrate the required production specifications. Some of these include how to test the…[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 reference document to demonstrate the required production specifications. Some of these include how to test the…[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 automatically considered a high risk and the notified body along with the competent authority evaluate the safety,…[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 automatically considered a high risk and the notified body along with the competent authority evaluate the safety,…[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 the clinical evaluations provided by the manufacturers and decide whether to pass or fail any device. Also, they are…[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 the clinical evaluations provided by the manufacturers and decide whether to pass or fail any device. Also, they are…[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 approving medical devices to be able to join the EU. With this combination of rules, the various countries came to an agreement…[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 had their respective rules and they all had to give up their individual rights for approving medical devices to be able to join the EU. With this combination of rules, the various countries came to an agreement with all of…[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 with the Intellectual Property of the company and making sure the contracted supplier agrees to the required terms. And what Dr.…[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 with the two possible designations individually, which one will match the intended therapeutic effect or action. This helps…[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 training. This would assist in having a consistent set of data collection and analysis. In addition,…[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 the industry. And even though I have taken the previous online courses like Orthopedic Medical Devices and the project management…[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 the company and possible tools of how they use to conduct business that can be easily start a law s…[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 that are part of the employee training in order to understand the difference from holding an event for educational…[Read more]