ISO 14155:2026, the fourth edition of the international Good Clinical Practice standard for medical device clinical investigations, has been published. It replaces ISO 14155:2020 and sets new requirements for risk management, Clinical Events Committees, Data Monitoring Committees, study design and adverse event reporting.
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Achieving inspection readiness ensures you're always prepared for regulatory inspections. Learn how to stay compliant and confident every day.
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Discover what happens during a regulatory inspection, what to expect from start to finish, and how to prepare for a smooth, stress-free inspection process.
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Inspection readiness tips: Learn how to manage fallout and improve with CAPA for better regulatory compliance.
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