Worldwide medical device QA/RA blog

News and commentary on changes to global regulations.

In Brief: Latest Version of ISO 13485 Published

The International Organization for Standardization 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's whitepaper.

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