I agree with the above statements, but in addition, missing a milestone is a bad thing no matter how you spin it. Take it as a learning experience for...
I think the best way to avoid an inaccurate estimation is to actually have members on the team that have done similar tasks before, you wouldn't want ...
jr377 taking into account how long the built in buffer should be is an important point to bring up. As with all parts of the project this too will be ...
In my opinion a good way to avoid scope creep is to have a highly efficient planing stage prior to the submission of a final scope statement. Make the...
Honestly I don't think there is a grey area on when to shut down or continue a project with an assessed risk. I think that when a risk analysis is don...
I think that the best way to prevent employees from going off on their own and making decisions that will effect the whole project, is to have a clear...
"High Complexity Tests This category includes those tests that are modified by the laboratory, developed by a laboratory, or a test classified as hig...
In an ideal world a company would fully fund projects large and small, but I think priority will ultimately come down to a risk reward analysis, how m...
In addition to giving ample time for members of the project team to review documents before their approval, I think that it would be beneficial to hav...
I haven't had the opportunity to work in industry yet, but if I could choose one of the nine parts of design controls to focus on I would choose desig...
I do not think that the medical device community as a whole is moving towards a globalization of regulatory procedures because as we have learned in l...
Over a medical device's lifetime the amount of information regarding its safety and effectiveness will increase and can possibly reduce the risk assoc...
With the standard pill, not containing the event marker, there were 6 clinical trials done to get the drug approved. With the addition of the marker t...