-
gh56 started the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices 8 years, 10 months ago
Hi everyone, so i watched Dr. Simon lecture and well risk analysis is a crucial position where you actually need to brainstorm really well and come out with all possible risk of the medical product that the company is trying to make to reduce any danger for the company and for the patients. If this is not brainstorm really well people life could…[Read more]
-
gh56 replied to the topic Important Part of DDP in the forum Introduction to Design Controls 8 years, 10 months ago
I have to disagree with you little bit, yes the communication management plan is important but I believe that every part of the design development is necessary. So I believe each have their own importance in the document and it should not be ignored because you think is not so important. Each give a piece of information that is necessary for the…[Read more]
-
gh56 replied to the topic Design Transfer in the forum Introduction to Design Controls 8 years, 10 months ago
I have to agree with you on this part a lot of smaller companies do hire separate companies to be able to manufacture their device since for them it cost efficient, if they try to do it for themselves that mean they need to spend a lot more money and since is a small company their profit would probably will not be enough if the small company…[Read more]
-
gh56 replied to the topic Design Review Meetings in the forum Introduction to Design Controls 8 years, 10 months ago
I haven’t had the change to have a design review meeting in an industry but I have done it when I was doing my Capstone project, we used to have a lot of meeting because we used to keep changing and updating our documents to make it better or maybe we forgot to add or fix some stuff, like Dr. Simon said in the lecture this is going to be a lot o…[Read more]
-
gh56 replied to the topic Design Verification & Validation in the forum Introduction to Design Controls 8 years, 10 months ago
I do have to agree with most of what you have said about design verification, we all know that design verification is pretty much to whatever it was written in the DID document it must be verified to make sure that it meets the input with the output, and to be able to do this each of the input that was in the DID document the engineer have to…[Read more]
-
gh56 replied to the topic Design Verification & Validation in the forum Introduction to Design Controls 8 years, 10 months ago
I do have to agree with most of what you have said about design verification and design validation, we all know that design verification is pretty much to whatever it was written in the DID document it must be verified to make sure that it meets the input with the output, and to be able to do this each of the input that was in the DID document the…[Read more]
-
gh56 replied to the topic Minutes for meetings in the forum Introduction to Design Controls 8 years, 11 months ago
I want to tell you that i believe that meeting minutes is extremely important specially when people have so much work and they might forget something this will allow to go back and figure out what was said. For me i believe this is crucial, sometimes i do forget thing so easily, so having meeting minutes will allow me to remember what it was said,…[Read more]