Cybersecurity • Regulatory Affairs

Medical Device Cybersecurity Risk Assessment

Published • • 9 min read

Filling in the cybersecurity risk assessment document and document tracker for Thailand 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.

Thailand's document tracker and cybersecurity risk assessment needed to close together, not as two separate exercises, if the recall closure across affected markets was going to hold up.

A living record for each market

A cybersecurity risk assessment isn't complete just because a document exists for a market. It has to be reviewed against the current threat and vulnerability list and reconciled with that market's own recall and document tracker.

Closing out Thailand’s record required:
  • Reviewing the existing cybersecurity risk documentation against the current threat/vulnerability list
  • Updating the risk assessment based on that review
  • Reconciling it with the recall and document tracker for the affected countries

What an unresolved vulnerability risks

An unresolved cybersecurity vulnerability being carried forward past a recall closure without documented residual-risk justification is exactly the gap a per-market review is meant to prevent.

What closing the record delivered

Closing out the cybersecurity risk assessment and document tracker gave the team a clear record supporting the recall closure across the affected markets, Thailand included.

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 filled in once per market and never revisited.

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