Certified processes and detailed control
We focus our attention on the quality and safety of our products to maintain a very high standard of quality. We use advanced systems of design, production and control to optimize our production and to eliminate the possibility of errors or defects.
We certify with our CE marking on all our devices that we are in accordance with Directive 93/42/EEC. The accurate monitoring of the production process through advanced computer systems ensures complete and continuous traceability of our devices. Our absolute respect for quality is the best guarantee of reliability.
ISO 13485 certification outlines in more detail the quality management system requirements that enable an organization to demonstrate its ability to provide medical devices and related services that abide by applicable regulatory requirements.
ISO 9001 quality certification certifies Mikai’s focus on procedures that ensure high quality standards and continuous improvement through customer feedback and addressing their needs.
All Mikai products are CE certified per Directive 93/42/CEE, as recently amended by Directive 2007/47/CE relating to active implantable medical devices and the authorization to commercialize a device within the European Union.
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