During post-launch product management, it is very important to keep track of the product's quality performance by interacting with the customers and k...

Hi gh56, I do not experience on this area yet. Nevertheless, I believe that it is difficult to pinpoint any role as the most important role for a prod...

If the machine severely failed in manufacturing, the first step is to investigate the root cause of the failure. Once the root cause has been found, a...

Hi all, After my undergraduate, I have to say that I really did not have any background knowledge of how the industry worked in regards to medical dev...

Hi all, Even though I still do not have experience in Validation, but I think that a type of Validation could also be Revalidation. Revalidation means...

HI gh56, I think that under the FDA the QSR embraces the same "umbrella'' approach to the CGMP regulation that was the underpinning of the original ...

For the Vascular Graft Weaving Line – weaving the polyethylene fabric tubes that make up a vascular graft... I believe that the IQ, OQ and PQ will be ...

Hi all, A DHR is a key deliverable from design controls and it is a checklist that is used during manufacturing of the device. The DHR, is created du...

Hi all, I have not had any experience with any ECO since I still do not have experience in the medical device industry. But to my understanding. some...

It is interesting to learn that Section 522 of the Federal Food, Drug and Cosmetic Act gives the FDA the authority to require a manufacturer to conduc...

Design verification tests whether each design output meets design input requirements. Therefore, individual design verification test aims to prove tha...

I believe that the DHF should be a living document that reflects the current state of the device. Keeping track of the changes (SOP'S, material, packa...

In my opinion, I think that the DHF is more useful. The reason for this is because this document is able to show a detailed and comprehensive design a...