Great news on the clinical evaluation world: ISO/TC 194 “Biological and clinical evaluation of medical devices” has approved the proposal of the new standard ISO 18969 – Clinical evaluation of medical devices!
The first draft was already reviewed and continued work on the new standard will start immediately, but the final document is expected to be published not before late 2025. If you are curious to know why it will take so long, please join me in this journey to understand the process of developing a new ISO standard!
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