CERTIFICATIONS

Rhein 83 began a process of “Quality System” in 1994, becoming ISO 9001 certified since 1996. In the same year the company obtained the first product accreditations from the FDA / USA and continued with certification: 1998-93 / 42 CEE – ISO 9001: 2015 – ISO 13485: 2016.

The “regulatory” activity is always monitored and constantly updated, for the maintenance of the current certifications, their renewal and the adaptation to the new rules for medical devices.

Below, the links to ISO and CE marking documents: