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.
Key products include:
- TotalExam®3 and TotalExam®HD, the world's easiest to use and easiest to hold examination cameras;
- eNcounter® Software to perform telemedicine consults and acquire close-up views of skin, eyes and throat
- eNcounter Cloud, a cloud-based application that securely preserves medical images in DICOM format to an electronic medical records PACS (Picture Archiving Communication System)
GlobalMed’s TotalExam camera bears the CSA certification for sale in Canada including a Certificate of Compliance, which adheres to the requirements of CSA International Standards.
GlobalMed’s product line also features products tested, certified, and declared to conform to IEC 60601 and FCC Part 15 for Medical Electrical Equipment. The TotalExam camera line features a CE Marking, demonstrating conformity to European medical device requirements.
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 9001 is an International Quality Management System Standard that specifies requirements within which an organization demonstrates its ability to consistently provide products or services that meet customer and legal requirements, enhancing customer satisfaction and opening the way to continual improvement. The requirements are intended to apply to all organizations, regardless of type, size or product/service provided. More than one million organizations globally have implemented ISO 9001 Management Systems, including 50,000 organizations in North America.
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.