Posted by: @quanzi A risk management file is the culmination of all documents related to the risk management process. It is a living document, and includes a risk management plan, risk analysis, risk evaluation, risk controls, the evaluation of overall…   Read more»

Posted by: @quanzi A risk management file is the culmination of all documents related to the risk management process. It is a living document, and includes a risk management plan, risk analysis, risk evaluation, risk controls, the evaluation of overall…   Read more»

@quanzi What specifically do you mean when you say that a “metal for a stent would be incompatible for use with a breast plant”?

@quanzi Yes, and “difficulty” of a medical device project has a number of facets to it.  There’s financial difficulty, technological difficulty, clinical difficulty, and others.

@quanzi Yes, and “difficulty” of a medical device project has a number of facets to it.  There’s financial difficulty, technological difficulty, clinical difficulty, and others.