Hi All, I would agree with the comments above that each role is important and it is difficult to say which would be most important. However, one that I believe is often overlooked, but still extremely...

Hi All, Thank you very much for your interesting question, I had not thought about this instance in the past. However I believe that it would make the most sense for a company to kill a project if it ...

Hi All, I was thinking about the Planning and Development phase of the Product Life Cycle. One of the most important aspect in this phase is the market and the evaluation of the market. Ensuring that ...

Hi All, This is a very interesting question that I had not thought about before. As was mentioned above if any changes, upgrades, or repairs occur on a machine it would need to be re-validated. Howev...

Hi All, Thank you for the great question. I feel these classes have greatly benefited me as well. I work mainly in the pharmaceutical side of the industry, with very little done in medical devices. H...

Hi All, I would agree that this simulation really shows the importance of having multiple vendors. It will limit delays like this and allows you to always have a backup plan. When only one vendor has...

Hi All, I do not have personal experience in this area however I could see why the quality team would argue that when equipment is moved all processes had to be revalidated. Most likely they were con...

Hi All, I believe that both require full verification of the process, but at different times. The FDA definition seems to be requiring full verification of the process by inspection and test, or 100%...

Hi All, After viewing the lecture for this week, I have thought about the IQ, OQ, and PQ for the Syringe Filling Process – filling syringes with an injectible bone void filler. IQ - meets specs includ...

Hi All, I would agree with those that stated the SOPs should contain as much information as possible. As soon as something is left up for interpretation, issues can occur. When issues occur and the i...

Hi All, I would agree with those that stated SOPs should be required during the research phase. Working for a start-up we did not have many SOPs in place. As more were hired we learned the hard way th...

Hi All, My best understanding is that the Design History File (DHF) contains all information about the development of the the product, as the design is created. It contains all inputs, outputs, and p...

Hi All, Post Market Surveillance is simply the process of monitoring a device after it is part of the market. It includes many aspects of a medical device, like device failure. There are even require...

Hi All, Thank you very much for this interesting topic. I have not worked too much with ECOs; however I do have a bit of experience. I have needed an ECO in the past for a change of an SOP. In most c...

Hi All, I was thinking about the differences that Dr. Simon highlighted in the lecture of the DHF vs. Tech File/Design Dossier. The DHF seems to be to be very complete and shows everything involved i...