December 2018 Standards Navigator Report

This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions.

Standards and regulatory activity overview

Medical device software

  • It appears that in response to a question posed by the IEC 62304 working group, the ISO and IEC member countries want ISO 14971 to be required for use of the second edition of IEC 62304. This should be reflected in the next committee draft of the standard.
Thank you for your interest!  To view our Premium or Standards Navigator content, please click here to select the plan that best fits your needs.

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!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.