Medical Device

Executable test criteria:

Medical Device

  • Medical related device IEC/EN/UL 60601-1, ANSI/AAMI ES60601-1 CNS14509
  • Home Care Device IEC/EN/UL 60601-1-11
  • Neuromuscular stimulator IEC/EN 60601-2-10
  • Special requirements for in vitro diagnostic medical device IEC/EN/UL 61010-1, IEC61010-2-101
  • Usability IEC/EN 60601-1-6, IEC/EN62366
  • Medical Device Software IEC/EN62304
  • Risk Assessment ISO 14971, ISO 13485 (Application Service),
  • Medical Device ship into many countries FDA 510 (k), KFDA, TGA, CE (Application Service)