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The IEC/EN-60601-1 standard is widely accepted internationally for the basic safety and essential performance of medical electrical equipment. New medical electrical equipment and medical electrical systems must demonstrate compliance with the latest revision of 60601-1, depending on where the device is sold.

From development through the review of your Risk Management File, ECM offers the following solutions to help you bring your medical device to market faster.

  • Risk Management Training for ISO 14971
  • Testing and Certification to IEC/EN 60601-1
  • Pre-test inspection
  • Test plan development