Wood Dale, IL – Sanyo Electric’s biomedical division says it has received ISO 13485 certification for the design and manufacturing of medical equipment.
ISO 13485 certifies that:
– an organization consistently demonstrates its ability to provide medical devices and related services that meet both customer expectations and regulatory requirements;
– there are controls in the work environment to ensure product safety;
– risk management activities are implemented during product development; and
– specific requirements are set for the verification of corrective and preventive actions.
The biomedical division produces laboratory equipment for pharmaceutical, life science and biotechnology applications. Product lines include ultra-low temperature freezers, cryogenic freezers, pharmaceutical and medical refrigerators, cell culture incubators, plant growth chambers, and portable autoclaves.