Cybersecurity • Regulatory Affairs

Medical Device Cybersecurity Risk Assessment

Published • • 3 min read

Reviewing cybersecurity documents for European countries in support of a recall closure showed that cybersecurity risk documentation has to be treated as a living record tied to each market's recall and safety-notice process, not a one-off checklist.

Closing a recall across European markets meant the cybersecurity risk documentation had to do more than exist. It had to reconcile with the recall and safety-notice process for each affected country.

A living record, not a one-off checklist

Cybersecurity risk assessments are easy to treat as a document produced once and filed. Tied to a recall, that assessment has to stay current against the threat and vulnerability list, or it stops reflecting the actual risk being closed out.

Closing out the assessment required:
  • Reviewing the existing cybersecurity risk documentation against the current threat/vulnerability list
  • Updating the risk assessment to reflect that review
  • Reconciling it with the recall and document tracker for the affected countries

What an unresolved vulnerability actually risks

An unresolved cybersecurity vulnerability being carried forward past a recall closure without documented residual-risk justification is exactly the gap this kind of review is meant to close before it becomes a finding.

Reconciling the record

Closing out the cybersecurity risk assessment and document tracker gave the team a clear record supporting the recall closure across the affected markets, one that ties the risk decision to the recall it was made for.

The Real Takeaway

Cybersecurity risk documentation has to be treated as a living record tied to each market's recall and safety-notice process.

Not a one-off checklist filed away once and forgotten until the next audit asks for it.

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