AAMI Standards Conference Software Session 2005

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Computerized Systems Used in Clinical Trials – Draft Guidance [9/04]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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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