FDA Medical Device Reporting webpage

The link provided is to the FDA Medical Device Reporting webpage. Although a number of the relevant regulation and some of the guidances are also posted separately, FDA has issued a number of amendments and continues to revise its interpretations of related compliance requirements; this FDA webpage is maintained and updatd directly by FDA. The MDR rule 21 CFR Part 803 defines what type of reports and time constraints apply for FDA reporting of significant field safety events or potential malfunctions that could lead to such events in the future.

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!

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.