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March 20, 2026
WARNING LETTER Exactech, Inc. dba Advita Ortho was issued a warning letter from the FDA. Excerpts from a warning letter of interest to SoftwareCPR® clients. CMS # 720250 2320 Nw 66th Ct Gainesville, FL 32653-1630 Date of inspection July 15-25, 2025 Inspection Issues: Quality System Regulation Violations This inspection revealed that these devices are adulterated...
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SoftwareCPR Training Courses

ISO13485:2016 ISO 13485 Internal Audit(or) Training Course (Live, 3-day)

IEC 62304 and other Emerging Standards Impacting Medical Device Software (Live, 3-day)

Being Agile & Yet CompliantISO 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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