CIM med GmbH fulfills 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 its 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 toward 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.
Managing Director Manuela Deverill regards the successful certification as an important quality feature for the sustainability of her company.
“Currently, we are a major step ahead of other suppliers on the market. We now permanently demonstrate our performance and our awareness for quality by complying with the latest standards in the development and production of our modern advanced carrier systems as well as through our highly efficient documented processes,” Deverill said.
In principal, all mounting solutions are inspected by CIM med for quality and functionality from development to delivery. They comply with the Medical Devices Directive 93/42/EEC and bear the CE marking. With regard to material resistance they meet the requirements of DIN EN 60068-2-74 as well as DIN EN ISO 2409:2013 and therefore are long-term resistant to disinfectants against multi-resistant pathogens. Furthermore, the Fraunhofer Institute attests that the support arms by CIM med can be cleaned and disinfected with wipes by “simple wipe cleaning.” As a medical product risk Class 1, all solutions conform with EN 60601-1, 3rd edition.
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