Day

May 25, 2015
The International Medical Device Regulators Forum (IMDRF) SaMD draft of a quality system for Software as a Medical Device is available for public comment.
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The ballot on the final draft of the IEC 62304 amendment, which focuses on safety classification and legacy software, closes in May. We expect publication by July, followed by a consolidated version that incorporates the amendment. Adoption by CENELEC as an EN is happening concurrently, so harmonization by the EU should happen late this year...
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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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