FDA Device Center draft Submission e-copy guidance

The device center at FDA has been requested and allowing electronic copies of submission information in a variety of forms for a number of years but with no standard approach. The draft guidance at the link provided is a step towards clarifying this and allowing e-copies to replace all but a certain number of paper copies (depending on submission type) provided there are signed paper certifications/cover letters with each e-copy.

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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

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