Day

November 24, 2021
A fundamental requirement for any controlled process is to have the documentation associated with the process to be “controlled.”  What do we mean by controlled?  Document control implies that one can distinguish one revision of a document from another revision.  It also implies that a particular revision is retrievable and unblemished – that is, five...
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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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