IEC 60601 medical product testing

IEC 60601: medical product testing

Access to the European medical market

As part of CE certification active medical devices must comply with IEC 60601 before they are allowed on the European market. At DEKRA we have laboratories located on different continents where these tests can be conducted.

DEKRA has been officially designated to completely implement the conformity assessment of the IEC 60601 for access to the EU market. We’re also accredited to grant access to markets in other countries and we can certify your quality management system.

DEKRA is a full service provider for medical device manufacturers. Consider these advantages:

  • Global presence
  • All testing and certificates provided by a single organization. In addition to testing IEC 60601* compliance, we also provide certification for ISO 13485
  • Were specialists with extensive experience in the medical industry