Changes to ISO 14155 standard for medical device clinical investigations expected in 2019

By Dietmar Falke Aleksandra Klimaszewski and Stewart Eisenhart, Emergo Group

Revisions to the ISO 14155 standard covering pre- and post-market clinical investigations for medical devices are set to take effect in 2019. Manufacturers and clinical trial sponsors should consider ramifications of the updated standard for risk management and related issues if they have not already begun doing so.

Get the full story here at the Emergo Group’s blog.

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