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Quality System Standards
As a provider of quality management system software (which is not classified as a medical device) Grand Avenue Software follows ISO 13485:2016 and 21 CFR 820 in the areas where it is applicable to our organization and manages those quality system processes using our own software. Grand Avenue’s quality manual describes how the company’s practices voluntarily align with medical device quality system requirements and is available to Grand Avenue customers upon request to support@grandavenue.com.
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