Hart Enterprises, Inc. is ISO compliant but not ISO certified.  Hart Enterprises, Inc. has been audited by many organizations including ISO notified bodies such as NSAI and found to “have developed and maintains a well documented and implemented management system.  Although the company is not independently certified to ISO 13485, the systems and processes in place are in conformance with this standard.”

Hart Enterprises, Inc. is an FDA Registered and inspected (registration #1828424) medical device manufacturer.