The draft AAMI Technical Information Report “Validation of software for regulated processes” has completed balloting. This document addresses software used to automate production and quality systems. The working group is resolving comments submitted and the timeline for release is Q1 2008.
IEC 62304 and other Emerging Standards Impacting Medical Device Software
Being Agile & Yet Compliant
ISO 14971 SaMD Risk Management
Software Risk Management
Medical Device Cybersecurity
Software Verification
IEC 62366 Usability Process and Documentation
Or just email training@softwarecpr.com for more info.
