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.

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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