GlobalMed® is a real-time healthcare delivery system company that deploys state-of-the-art medical data and images to the cloud, providing access anywhere. GlobalMed has developed hardware, software and service solutions to enable leading healthcare professionals to be more effective in providing patient care, and more productive and efficient in managing patient information. Key products include: TotalExam™2 and TotalExam™HD, the world’s easiest to use and easiest to hold examination cameras; CapSure®Image Automation Software to acquire close-ups of skin, eyes and throat; and CapSure® Cloud, a cloud-based application that securely preserves medical images in DICOM format to an electronic medical records PACS (Picture Archiving Communication System).
The TotalExam™ has received approval by the Australian Register of Therapeutic Goods (ARTG) as a “Medical Device - Class 1 - Included.” View Certification.
GlobalMed’s TotalExam™ camera bears the CSA certification for sale in Canada and in European countries that adhere to the standards after receiving the Certificate of Compliance from CSA International.
GlobalMed also has received the FCC part 15 subpart B Class A and the CE Mark Declaration of Conformity (DoC), including the IEC 60601-1-2 “Medical Electrical Equipment” mark for the TotalExam™ camera. CE Mark clearance from the European Union certifies GlobalMed® has met health, safety and environmental, safety and environmental requirements for consumer safety.
GlobalMed’s cloud-based solutions transmit “Protected Health Information” in electronic form, and, as such, qualifies as a Business Associate under the U.S. Department of Health and Human Resources description. Accordingly, GlobalMed has adopted a General HIPAA Compliance Policy in order to recognize the requirement to comply with the Health Insurance Portability and Accountability Act (“HIPAA”).
Quality Management System
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.
ISO 9001 is an International Quality Management System Standard that specifies requirements within which an organization demonstrates its ability to consistently provide product or service to meet customer and legal requirements, enhancing customer satisfaction and opening the way to continual improvement. The requirements are intended to be applicable to all organizations, regardless of type, size or product/service provided. Globally more than one million organizations have implemented ISO 9001 Management Systems (50,000 organizations in North America).