ISO 14155 – Good Clinical Practice for Medical Devices
Are you involved or interested in using medical devices in clinical trials? Be among the first to learn about the significant upcoming changes in the International Standard Organization (ISO) 14155 standard.
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Are you involved or interested in using medical devices in clinical trials? Be among the first to learn about the significant upcoming changes in the International Standard Organization (ISO) 14155 standard.
The ISO 14155 ‘Clinical investigation of medical devices for human subjects – Good clinical practice’, coined ‘Medical device GCP’, addresses design, conduct, recording and reporting of clinical investigations carried out in human participants to assess the clinical performance, effectiveness, and safety of medical devices. It is embedded into the Canadian Medical Device Regulations, and training is mandatory for those involved with or using medical device in clinical trials.
A new updated version of ISO 14155(2025) has passed the final stages of the approval process and is expected to be released within the coming weeks to replace the existing ISO 14155(2020).
Don’t miss this opportunity to learn more about this impactful change.