Day

March 22, 2016
The link provided is our revised checklist for changes in Amendment 1. You will need to login as a paid subscriber to download this checklist.
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Amendment 1 of” “IEC 62304 Medical device software — Software Life cycle processes” was issued in 2015. Although the focus of the Amendment was to include a special provision for Legacy software as well as clarifications and changes to Safety Classification, a number of other substantive changes were made.including significant additional requirements for Class A...
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http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077862.htm
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Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
for more info!

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