ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
For more information visit the ISO website @ https://www.iso.org/standard/59752.html
ISO 9001 sets out the criteria for a quality management system and is the only standard in the family that can be certified (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.
For more information visit the ISO website
The E.U. legislation has been updated to keep up with technical advances and changes in medical practice to create a more robust, transparent, and sustainable regulatory framework. Eudamed with the Italian Ministry of Health recognized us as a verified entity and assigned us an SRN code.
100% Made in Italy
Made in Italy is a merchandise mark indicating that a product is all planned, manufactured, and packed entirely in Italy. Acknowledging the value of Made in Italy and promoting it is crucial to make the quintessential excellent Italian product known among all consumers.
Cobat RAEE is a non-profit private law consortium, consistent with the provisions of the law imposed on Collective Financing Systems, in relation to Legislative Decree 49/2014, it is a collection and recycling system accredited to the WEEE Coordination Center. Cobat RAEE takes advantage of Cobat’s thirty years of experience in the management of technological waste.