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    Post-Production Information (Risk)

    ISO 14971 requirement to feed real-world post-market data back into the risk management process.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Manufacturers must establish a system to collect and review production and post-production information - complaints, service data, MDRs, literature - and update risk estimates and controls when needed.

    What this means in practice

    PPI is the loop that connects PMS/vigilance to the risk file; weak PPI handling is a common audit finding under MDR.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·2AAMI·1
    1. 1
      ISO 14971 Cl. 10
      Verified
      ISOiso.org
    2. 2
      ISO 13485 Standard Page
      Verified
      ISOiso.org
    3. 3
      AAMI - Quality Systems Resources
      Verified
      AAMIaami.org

    Inline markers like [1] jump to the matching reference above.