Hi Fady, I have to agree with chris vasquez, there is no need to revalidating something that is not being move. what is important here is understand what went wrong with me machine it seem that some components of the…   Read more»

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…   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….   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   Read more»