I haven’t had no experience in this aspect but I did some research on different type of validation and I found that, self-documenting verification method is the traceability matrix. This method is particularly useful when the design input and output are both documents; it also has great utility in software development. In the most common form of t…[Read more]

Hey guys we have talk about IQ, OP and PQ about Syringe Filling Process – filling syringes with an injectable bone void filler and Vascular Graft Weaving Line – weaving the polyethylene fabric tubes that make up a vascular graft. Now I have a question about the CGMP (current good manufacturing practice) in manufacturing this two devices. We kno…[Read more]

Hi Andrew, I have to agree with Fady Khalla on your IQ but never the less I think most of people have gave a lot of input on the syringe filling process for IQ, OQ, and PQ. so im just going to say that the IQ test plan for the syringe would contains detailed information on how the test are going to be performed on this respective device. Than the…[Read more]

I wish i had experience on QMS for me it seems very important since quality management system can be defined as the implementation of dedicated activities in a project to obtain continuous improvement, and enhance the organization efficiency. The foremost effort of this system is to correctly and precisely define the procedure that will cause…[Read more]

I have to agree with Jnm22 and mj34 but I want to add a little more about this that I think is important. We first need to understand that post-market-surveillance is to pretty much monitoring a device after is out in the market. Mostly how we going to monitor these devices is by the consumers, which would be our customer, they can be doctors,…[Read more]

A written method of controlling a practice in accordance with predetermined specifications to obtain a desired outcome. SOPs are written steps to explain good manufacturing practices (GMP), plant safety routines, financial controls to secure assets, or IT security measures that employees are to follow. so we know that SOP is a step by step…[Read more]

nice information you have found neb2 i have post two more that i think it crucial to know all the surveillance strategies.

4. Postmarket Surveillance Studies — The FDA may order a manufacturer of certain Class II or Class III devices to conduct postmarket surveillance studies (often referred to as “522 studies”).3 Study approaches vary widel…[Read more]

i see a lot of you have gave their opinion on the matter of how to trying to get the best strategy to take when the validation and verification had fail. Now we know is really bad when this two fail, so we have to make sure before everything is done properly to “never” counter this matter, so we have to consider that instead of rushing to design…[Read more]

I have to defiantly agree with neb2, the DHF is a lot more useful than the design dossier since this file have detailed information bout the design, function, composition, use, claims and clinical evaluation of the medical device and it seem important but there a lot other information that is missing and I believe that the DHF have a lot of more…[Read more]

When talking about verification is like asking our self are we building the system right? We always have to consider this question when we are talking bout verification. It is important that the process of the evaluating products of a development phase to find out whether they meet the specified requirements. Now when we are talking about…[Read more]

Hi Jnm22,
Thank you for providing this information, it was interesting in actually looking up the wake forest I did not know nothing about it. It was interesting in reading it about it. Yes I do I agree on this matter that there a many problem to be able to putting all this techniques together is going to be hard to achieve but how technology keep…[Read more]

I have to 100% agree with you I love your post, we have seen what 3D printing can do and how it can advance the technology in the medical field which allow us to help more patients health, which this is our major find ways to make it easier and better to prolong the life of someone. I do believe that 3D printing in the medical field is going to be…[Read more]

I have to 100% agree with you I love your post, we have seen what 3D printing can do and how it can advance the technology in the medical field which allow us to help more patients health, which this is our major find ways to make it easier and better to prolong the life of someone. I do believe that 3D printing in the medical field is going to…[Read more]

I want to talk a little more about the 3-D printing , we have learn that 3D printing is becoming more popular now days, the cost of getting one is really cheap, and many people can just go and purchase one and try to design something and printed, not many skills are needed to learn how to used it. Now, we as a scientist and engineers are taking…[Read more]

I have too semi agree with you, yes the written agreement is important to be able to have strong argument in the court this will allow you to have a better chance to be able to win if something went wrong. But I don’t believe that verbal agreement is actually good, this reason is because 1 you have to back it up and in this world money is i…[Read more]

I do not have experience with this matter since I haven’t been able to work in a company where I have to deal with this matter but I do have to agree with Zmh4 on his point of view, it seem it was a violation of an NDA or CDA, the reason why I believe that is a violation is because when it comes to agreements, they should different from each c…[Read more]

When I sign for this class I wasn’t sure what was about, but I am happy I took it because it allows me to learn different type of work you can do in the medical device industry. With the knowledge I have gather from this whole semester I am more clear to which position are available in the medical device industry. I have enjoyed so much the l…[Read more]

I haven’t had the opportunity to be part of this kind of organization, but neither the less, both organization have their advantages and disadvantages as how Dr. Simon mention in the lecture. Both organization seem pretty cool to be part of, and I wouldn’t mind working for either one, but one thing that will me to pick one from the other one is…[Read more]

You have raise an actually good question, if you don’t have a choice to pick your team and is already selected for you yeah that would be a different problem. I believe your list accurate and it make sense, but what is most important about to try to not have no conflict or disagreement, the first thing that I believe is the most important is t…[Read more]

This is a little difficult question to answer, ideally you should pick the best at the department roles that way everyone knows their role and try to focus on the goal project, but I think that would be only in a perfect word, and this is not a perfect world so, we have to account the personality of people that is going to be in our project team.…[Read more]