20
Nov
2006

FDA ADVAMED Software Regulation Presentation

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0

Jim Callaghan of FDA’s Office of In Vitro Diagnostics gave a presentation on Medical Device Software Regulation. This presentation covers all types of devices but then focuses on some specifics for devices used in clinical laboratories. The slides are at the link provided.

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

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