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 been selected, you are…   Read more»

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 concerned that when equipment…   Read more»

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% testing of a process. However taking:…   Read more»

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 including the amount of…   Read more»

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 individual followed the SOP to…   Read more»

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 that without…   Read more»

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 protocols. The Device History Record (DHR) is…   Read more»

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 requirements for some Class II and…   Read more»

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….   Read more»

Hi All, Verification and validation of a process includes making sure that process and all aspects of it are meeting the correct specifications. As was stated above this would involve ensuring that equipment used during testing is giving accurate results….   Read more»

Hi All, I would say that the school of thought that appeals to me most is that the DHF is not a living document. As small processes change over time they can be inserted into the DMR, but not change…   Read more»

Hi All, I was thinking of one way that getting a medical device approved in the EU may be more difficult than in the USA and only thought of one: It may be difficult for a small, US based company…   Read more»

Hi All, I would agree that devices would be easier to get approved in the EU for a number of reasons. The main reason being that the classification is purely based on a checklist and risk. This allows a device…   Read more»

Hi Fady and Luisa, I would agree that it is a difficult measurement to simply say that every time a certain number. However I would agree with Luisa that a study needs to be clearly defined and there needs to…   Read more»

Hi All, I currently work in the pharmaceutical industry assisting pharmaceutical companies to outsource their pre-clinical research. I have also looked into medical device research outsourcing as well. One of the main trends I can see is the outsourcing pre-clinical…   Read more»

Hi All, Thank you very much for the very interesting topic. I would agree that the restrictions in theory seem to be very strict. However I would agree with the level that they are set at. This is due to…   Read more»

Hi All, As the previous posted mentioned a written contract is greatly needed if any piece of the matter needs to be protected from a legal point of view. Oral contracts are extremely difficult to defend in court as it…   Read more»

Hi All, I believe that this was a very interesting course. As others previously mentioned, I believed that it would be a course that would involve more about theory of medical devices. I found this course very useful, as I…   Read more»

Hi All, I would agree that all who posted that stated a Matrix organization would be ideal. This is due to the fact that a project based organization puts much responsibility on the project manager and their team. In an…   Read more»

Hi All, I would say that the best type of organization would depend on the specific company, but I would consider starting as a matrix organization. As a matrix organization, everyone would know each other, and knowledge would transfer well….   Read more»