In brief: Latest version of ISO 13485 published

By Stewart Eisenhart, Emergo Group

The International Standards Organization has officially published the highly anticipated update to its ISO 13485 quality management system standard.

ISO 13485:2016 updates will impact several quality processes and procedures for medical device companies whose compliance to the standard is required for registrations in various markets worldwide.

Additional analysis of ISO 13485:2016 changes is available via Emergo’swhitepaper.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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