It contains all software and computer related recall excerpts for the years listed. Some of the newest recalls on the site may not be included.
This compilation is provided in reverse chronological order and is useful for quick review, searches, circulation, and training purposes. A similar document is provided for warning letters.
You can request specific filters and sorts of this information by going to the catalog on the website.
IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software
ISO 14971 Risk Management (typically with heavy emphasis on software aspect)
IEC 81001-5-1 Cybersecurity Lifecycle
ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits
Being Agile Yet Compliant (AAMI TIR 45)
IEC 29119-1 Software and System Testing
US Classification for Software Devices
IEC 62366 Usability Process and Documentation
Or just email training@softwarecpr.com for more info.
