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medical device clinical investigation

ISO 14155 Update in 2019: Key Changes for Medical Device Clinical Investigations

EMERGO by UL SUMMARY OF KEY POINTS:

  • The third edition of the ISO 14155 standard for medical device clinical investigations is expected in 2019.
  • Broader risk management requirements are a key feature of the revised ISO 14155.
  • Final publication of ISO 14155’s third edition will likely occur in mid-2019.

ISO 14155 Third Edition Preview: Role of Risk Management in Clinical Investigations

EMERGO SUMMARY OF KEY POINTS:

  • The anticipated update to ISO 14155 in 2019 includes stronger requirements for clinical risk management.
  • The third edition of the ISO 14155 medical device clinical investigation standard will align more closely to ISO 14971 medical device risk management concepts.
  • Quality management principles applied to clinical investigation audits are also introduced in ISO 14155’s latest edition.