Day

October 15, 2019
One of the first steps on the marketing pathway for a medical device is to classify your device. As technology and innovation continue to advance, determining how to classify a device can be complex and challenging. This session will provide information on interacting with FDA for device determination and an introduction to Section 513(g) Requests...
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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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