An ISO 141552020 Primer — Good Clinical Practice For Medical Device Trials
An ISO 14155:2020 Primer â 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 re...
Source: meddeviceonline.com