OXOS Cybersecurity Remediation

OXOS Medical, Inc

FDA Cybersecurity510kSIMDCybersecurity

The Problem

OXOS Medical is the manufacturer of ultraportable X-ray imaging systems for point-of-need radiographic diagnostic imaging. They’re an established manufacturer with previous experience submitting and clearing devices with the FDA. For their latest device, the MC2 Portal Portable X-ray System, they needed help quickly putting together cybersecurity documentation for an upcoming 510(k).

Highlights

  • The OXOS MC2 device successfully achieved FDA Clearance, supported by cybersecurity guidance from Innolitics through multiple rounds of correspondence with the FDA.
  • Innolitics worked quickly to identify and address cybersecurity requirements in the OXOS MC2, allowing for submission within the target timeline.

What We Did

  • Performed an initial cybersecurity gap assessment, identifying all the areas that needed to be addressed before submission. These included specific documents, security controls and updates to current procedures.
  • Met with OXOS every week until the submission to address cybersecurity gaps.
  • Drafted several new cybersecurity documents.
  • Guided updates to company procedures to comply with FDA cybersecurity guidelines.
  • Helped draft new software requirements to comply with FDA cybersecurity guidelines.
  • Provided support for FDA Additional information Request and Interactive Reviews.

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