Day

July 12, 2020
You are likely aware of the CAPA process overall and how it fits in to the quality management system for a medical device manufacturer or supplier.  Just the name itself, corrective and preventive action, describes one of the core values of quality management.  Surely we are all motivated to identify and correct problems and issues...
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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.

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