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An ISO 14155:2020 Primer — Good Clinical Practice For Medical Device Trials By Sandra SAM Sather and Jennifer Lawyer, Clinical Pathways, LLC The International Organization for Standardization (ISO) recently released ISO 14155:2020, Clinical investigation of medical devices for human subjects Good clinical practice, 1 a standard developed to guide clinical research professionals during the design, conduct, recording, and reporting of clinical trials related to the safety and effectiveness of medical devices. For post-market clinical trials, it should be followed as much as it is relevant to the particular clinical trial or according to regional requirements. The standard outlines requirements to: Protect of the rights, safety, and well-being of human subjects,

Eteläuomen läiUnited statesNorth carolinaResearch triangle parkInternational organization for standardizationClinical pathwaysEuropean medicines agencyAssociation of clinical research professionalsAssociation for clinical research professionalsJennifer lawyerInternational organizationEuropean medical device regulationGood clinical practiceReflection paperRisk based quality managementClinical trials