Tag

soup
30
Aug

SOUP – Can’t Live Without It!

August 30, 2021
Software of Unknown Provenance SOUP.  It is likely that you are familiar with the acronym, SOUP, in relation to medical device and Health IT software.  The medical device software standard IEC 62304, defines SOUP as a “software item that is: already developed and generally available and that has not been developed for the purpose of being...
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30
Oct

Understanding OTS and SOUP

October 30, 2020
Understanding OTS and SOUP is very important in every lifecycle stages of medical device and HealthIT software development.  In the late 1990’s, the US FDA first published guidance documentation on the use of Off-The-Shelf (OTS) software in medical devices (or sometimes referred to as “OTSS”).  At that time, OTSS generally accounted for a very small...
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22
Mar

White Paper Compliant Use-Microsoft Visual Studio

March 22, 2014
The link provided is to a white paper prepared by Northwest Cadence regarding use of Microsoft Visual Studio to aid in compliance with FDA requirements. Food and Drug Administration (FDA) Compliance with Visual Studio 2010
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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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