Medical Device Clinical Trials

The International Organization for Standardization (ISO), a network of national standard bodies that develops voluntary standards, has recently released a new, revised version of their global clinical research standard; ISO 14155: Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice.  The ISO 14155 has been updated to the third edition and released in July 2020.  The previous version was released in 2011.

ISO 14155 addresses GCP for medical device studies including the design, conduct, recording, and reporting of clinical investigations. This new edition strengthens the risk management requirements across all phases of the clinical investigation process, including pre- and post-market clinical investigations.   If you would like a copy of the new ISO standard, check out the ISO webpage.

Unlike ICH and FDA Guidance documents, ISO standards need to be purchased for use.

 

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