Day

August 25, 2025
Updated: Final guidance released August 25, 2025. View the document: 2025-08-Guidance-Predetermined-Change-Control-AI The US FDA has a continuous challenge trying to ensure that regulations keep up with advancements in technology.  As with any new technology, manufacturers try and make the existing regulations applicable, while FDA assesses whether or not existing regulations are appropriate for the new technology. ...
Read More

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.