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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, ....

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