FDA CDRH 510(k) Reqs for Firms Initiating Recalls

FDA Blue Book Memorandum K95-1 “510(k) Requirements During Firm-Initiated Recalls”. Is at the link provided. It explains and provides a flowchart on the options. Note that it indicates FDA needs to be in the loop and agree with choices and approach during a reportable recall.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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