Warning Letter Excerpts – Jan 2014 to Sep 2018

The attached pdf file contains all software and computer related warning letter excerpts posted on this site for the years listed. Some of the newest warning letters on the site may not be included since we only update this comprehensive document periodically.

This compilation is provided in reverse chronological order and is useful for quick review, searches, circulation, and training purposes. A similar document is provided for recalls. You can request specific filters and sorts of this information by going to the catalog on the website.

Scpr Warning Letters Report (2014-present)

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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