Comments Requested on FDA Software Guidances

The AAMI software committee is preparing comments on the “FDA Guidance for the Content of Premarket submissions for Software Contained in Medical Devices” in the interest of providing FDA input for future revision of this and related guidances. If you are not a member of the AAMI software committee and would like SoftwareCPR (a member of AAMI with representation on several working groups) to incorporate your comments for review by the committee you can send them to our Managing Partner at alan@softwarecpr.com.

SoftwareCPR Training Courses

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.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.