April 1, 2016 — Pyrexar Medical announced the achievement of ISO 13485 Certification and CE re-certification for its line of hyperthermia products for cancer treatment.
ISO 13485 represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. The ISO standard is also a required compliance to do business in the European Union.
The CE Mark allows Pyrexar to ship medical devices to any of the 27 member states of the EU.