Glossary Term
ISO 14155 (Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice)
Definition
ISO 14155 is an international standard that establishes guidelines for clinical investigations of medical devices, ensuring they are conducted ethically and in accordance with good clinical practice (GCP). The standard aligns with global regulatory requirements and focuses on protecting patient safety, ensuring data integrity, and supporting regulatory submissions.
Relevance to the MedTech Industry
ISO 14155 ensures that clinical investigations are ethically sound and scientifically valid, enabling manufacturers to generate credible evidence of safety and performance for regulatory approvals, market access, and product optimization.
Additional Information & Related Terms
Key Sections of ISO 14155
Ethical Considerations
Protects the rights, safety, and well-being of study participants, in line with the Declaration of Helsinki.
Clinical Investigation Planning
Emphasizes robust protocol design, defining objectives, methodology, endpoints, and statistical analyses.
Sponsor and Investigator Roles
Clarifies the responsibilities of sponsors, investigators, and other stakeholders in ensuring compliance with GCP.
Risk Management
Integrates ISO 14971 principles to address potential risks to participants during the study.
Data Management and Reporting
Ensures data integrity, transparency, and proper reporting of adverse events and study outcomes.
Related Terms
Good Clinical Practice (GCP): Ethical and scientific principles guiding clinical investigations, as outlined in ISO 14155.
Post-Market Clinical Follow-Up (PMCF): Ongoing studies conducted post-approval to ensure long-term safety and performance, aligned with ISO 14155 principles.
ISO 14971: Provides risk management guidelines that are integrated into clinical investigation planning under ISO 14155.
Regulatory Submissions: Clinical data generated under ISO 14155 supports applications like FDA 510(k) or CE marking.