November 12, 2014 – At the end of January 2014 Portavita received the ISO certification for the ISO 13485:2003 standard. DEKRA recently conducted a first surveillance audit. The auditor concluded that Portavita again shows that it meets the high international quality standards and thereby retains the certification.
ISO 13485:2003 is an international standard related to quality management systems in the field of medical devices. ISO 13485:2003 covers the design, the development, production, implementation and services of medical devices.
The Portavita Anticoagulation Module is a Medical Device class I and as such CE marked.