AAMI Standards Conference Software Session 2005 including 4 FDA presentations
The following are all included in the pdf at the following link: AAMI Standards Conference Software Session 2005

Review of Software in Premarket Submissions (new guidance for CDRH and CBER)
– David S. Buckles FDA CDRH ODE
Cybersecurity for Networked Medical Device Containing (OTS) Off-the-Shelf Software
– John Murray FDA CDRH Office of Compliance
Computerized Systems Used in Clinical Trials – Draft Guidance [9/04]
– Patricia Beers Block FDA Office of the Commissioner
AAMI TIR32:2004 Medical Device Software Risk Management – Purpose & Scope March 2005
– Paul Jones – FDA CDRH OSEL
AAMI TIR32:2004 Medical Device Software Risk Management – Content Overview & Status March 2005
– Alan Kusinitz SoftwareCPR®
Risk Management in IEC 62304 CDV
– Sherman Eagles Medtronic