The Electrospinning Company has updated its Quality Management System to the new ISO 13485:2016 standard for the design, development, manufacture and supply of electrospun polymer scaffolds, and has been re-certified for a further three years.
The ISO13485 standard has been updated from 13485:2003 to 13485:2016 to keep up with changes in the medical device industry and to address changes in the underlying ISO 9001 standard. The new version places greater emphasis on risk management and risk-based decision making processes and is more closely aligned to the US FDA 21 CFR Part 820 quality system regulations.
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