ISO 13485 is the quality management system standard for medical device manufacturers and their sub-tier suppliers and subcontractors. Based on the ISO 9001 standard, ISO 13485 includes additional requirements for medical device manufacturers to demonstrate their intent to comply with applicable regulatory and statutory requirements. ISO 13485 is recognized as an aid in supporting compliance with the Medical Device Directive.
AUS ISO 13485:2016 Certificate
Why Choose AUS?
Advanced Ultrasound Systems has invested heavily in our new facility and has one of the most extensive new and refurbished parts, probes, and systems inventory in the business. We take great pride in our reputation for doing whatever it takes to keep our customers happy and up and running with minimal downtime.
At AUS our customer service philosophy is that "The customer is always #1."