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ISO 14155

ISO 14155 Revisions to Substantially Impact Clinical Investigations

The International Organization for Standards (ISO) recently published a revision of its ISO 14155 rule governing clinical trials for medical devices, ISO 14155:2011, and manufacturers will have several new requirements to address in order to comply. (An overview of the revised standard is available from Excel Translations.) ISO 14155:2011 follows ISO 14155:2003 and ISO 14155:2009, European standards applied to medical device clinical investigations.

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.