Patient Monitors and Other Products from Infinium Meet Medical Regulatory Requirements
When purchasing patient monitors and other medical equipment for your facility, you want to be sure that it is safe, durable, and meets all necessary regulations. At Infinium Medical, we manufacture a variety of patient monitoring equipment that meets all major USA and international regulations. We know how important having safe and reliable medical monitors and equipment is, we design and build devices that give you peace of mind.
Our equipment meets requirements for:
- U.S. Food and Drug Administration (FDA)
- CE Mark (Europe)
- IEC 601-1 patient safety standards
- UL and CSA electrical standards
- ISO 13485 Quality Systems – Medical Devices
- Good Manufacturing Practice (GMP)
Not only are our patient monitors compliant with federal regulations and the requirements of many other governing bodies in the international medical community, but we are also dedicated to providing our customers with the most well-built, yet affordable patient monitoring technologies available.