Day

August 3, 2017
The FDA held a meeting and webcast regarding initial development of its new approach for Digital Health Regulation. The FDA’s Digital Health Precertification webpage is at the link provided, and the slides from their presentation can be downloaded.
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"Based upon the company’s precertification level and the level of risk for the device, the product (or modifications to a product) may be able to go directly to market or undergo a streamlined submission review"
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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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