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ISO 13485:2016 successfully implemented by CIM med GmbH

CIM med GmbH fulfils the requirements of the new ISO 13485:2016. This makes the internationally operating manufacturer of medical-grade mounting solutions one of the first suppliers on the market who has consistently translated the stringent requirements of the new standard into their management system.

The changes of the new standard versus the previous version dated 2003 primarily affect risk management, which now includes all processes of the management system. Also, the focus is now increasingly directed towards feedback mechanisms and the more intensive monitoring of suppliers as well as outsourced processes. Furthermore, design and development requirements were refined (plans and proof of verification, validation and design transfer). Altogether, the new ISO norm takes the requirements of the 21 CFR (Code of Federal Regulations) part 820 into account to a much higher extent.

Exhibitor: CIM med GmbH

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