The US Law PLAW-114Publ255 referred to as the 21st Century Cures Act published in Dec 2016 is at the link provided. There are many important elements of this law for Drugs, Devices, and Biologics.
The US Law PLAW-114Publ255 referred to as the 21st Century Cures Act published in Dec 2016 is at the link provided. There are many important elements of this law for Drugs, Devices, and Biologics.
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.