FDA Letter with extension of deadlines UDI

FDA issued a letter to Device Labelers on Sept. 6, 2016 extending the deadlines for UDI lablel and GUIDID submission requirements for certain Class II products and certain combination products to Sept. 14, 2018. The full letter details the specific device types is at the link provided.

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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