Quality Certifications

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GlobalMed® is a real-time healthcare delivery system company that deploys state-of-the-art medical data and images to the cloud, providing access to care at any location. GlobalMed has developed hardware, software and service solutions to enable healthcare professionals to be more effective in providing patient care, and more productive and efficient in managing patient information.

GlobalMed’s product line features products tested, certified, and declared to conform to IEC 60601 and FCC Part 15 for Medical Electrical Equipment.

GlobalMed’s cloud-based solutions transmit Protected Health Information in electronic form. As such, GlobalMed qualifies as a Business Associate under the U.S. Department of Health and Human Resources description. Accordingly, GlobalMed complies with the Health Insurance Portability and Accountability Act (HIPAA) through our General HIPAA Compliance Policy.

Quality Management System

ISO 13485 is the quality management system standard for medical device manufacturers and their sub-tier suppliers and subcontractors. 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.