FDA Safety Alert – Stereotactic Navigation Systems

FDA issued a Safety Alert to users of Stereotatic Surgical Navigation Systems. This alert provides a vareity of warnings and recommmendations to prevent deaths and serious injuries when using these systems including software issues and medical imaging issues among others. The full alert is at the link provided.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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