Day

March 7, 2020
March 2, 2020 Excerpts from a warning letter of interest to software professionals: 1.b. Validation of device software is inadequate and is incomplete. Specifically, your firm did not conduct or document the results of software requirement specification and software design specification in your software verification and validation report for your Class II Swaive Thermometer. The...
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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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