In summary, XP Power Medical Standards are based on 2 levels of Protection, Operator Protection and Patient Protection. 3rd Edition requires Risk Management file, XP Power has a Risk Management process around ISO 14971 and further develop it with guidance from UL. XP Power also has gotten full ISO 13485 Quality Management Systems for Medical Device Manufacturers approvals on the factory. For additional assistance please feel free to contact DigiKey Technical Support or by visiting XP Power’s website at www.xppower.com.