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.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
The post Changes to ISO 14155 standard for medical device clinical investigations expected in 2019 appeared first on MassDevice.
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