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ISO 13485:2016 Certification
Certifications
ISO 13485:2016 quality management system certification across 9 EXALTA facilities. Covers design, development, production, and servicing of medical devices. Certificate FM 701546, valid through July 2028.
ISO 13485:2016 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.
Certified Facilities
The following EXALTA facilities maintain ISO 13485:2016 certification: