During post-launch product management, it is very important to keep track of the product's quality performance by interacting with the customers and keep track of it. This way you are ensuring that cu...

As mentioned in the lesson, the product life cycle curve has different phases and each one contains a different set of characteristics. These phases are: - Development - Introduction - Growth - Maturi...

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 product manager since they are equally important and t...

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 correction must be performed. If the failure can ...

One of the skills that is mostly taken for granted is technical writing. As engineers, we are not only solving problems but working with new products, nevertheless, documentation of your work is also ...

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 devices. I learned a lot from part 1 and part 2 MDD. ...

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 repeating the original validation effort or any p...

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 CGMP regulation. Because the regulation must apply ...

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 as following: IQ- The machine weaving the polyethy...

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 during design controls but it is not used until manuf...

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 examples in which ECO is needed could be when a m...

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 conduct post-market surveillance of a class II or class ...

Design verification tests whether each design output meets design input requirements. Therefore, individual design verification test aims to prove that each design output complies with each specificat...

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, packaging, labeling..etc) and updating the DHF gives an...

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 and development process until its release. Every ch...