ASPYRA, LLC (ASPYRA), a market leader in PACS, released today that it has received certification for ISO 13485:2016 for its PACS product through Intertek. This certification provides assurance to customers and prospects that ASPYRA’s Quality Management System meets the requirements of the ISO Standard 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes.
Aspyra’s Director of Regulatory Affairs, Mr. Raymond Pizinger states: “Many people don’t realize that software can be a medical device. As such, it’s very important to maintain a high level of quality in design, development, support and operational processes to insure that the products produced and offered for sale meet the stringent quality standards that have been established for product reliability and patient safety. The ISO 13485:2016 certification process verifies that Aspyra has met and continues to meet these high standards.”
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