FDA New eCOPY for Medical Device Submissions

FDA issued “eCopy Program for Medical Device Submissions” guidance dated Dec. 3, 2015. This document is at the link provided and replaced the prior version dated Oct 10, 2013. Electronic copies are required for many types of submissions to FDA. Section 6 Table 1 indicates which submissions require ecopies and how many and which are voluntary. Attachment 1 provides technical standards for ecopies and they are organized PDFs and FDA encourages use of bookmarks and hyperlinks.

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

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