The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
A team headed by Columbia University Professor Kelly Posner designed the Columbia Classification Algorithm for Suicide Assessment (C-CASA) and the Columbia Suicide Severity Rating Scale (C-SSRS) mentioned in the guidance.
Now FDAnews has invited Dr. Posner to explain how C-CASA and C-SSRS work... and how you can use them in your own clinical trials.
Audio CD/Transcript - Jan. 25, 2011
The Audio CD/Transcript will be shipped the week of Feb. 21, 2011.