Medical images on a tablet PC

Medical Technology Testing

Testing of wireless medical technology at cetecom advanced

The field of medical technology is diverse and highly innovative. The technologies used in medical devices have multiplied at a breathtaking pace in recent years. It must be ensured that mobile communication technologies in medical devices do not have any harmful effects on health due to high-frequency electromagnetic fields. In addition to cetecom advanced’s contribution to ensuring radiation compliance, cetecom advanced supports the medical industry with expert advice, testing and certification solutions to ensure that your product meets the required quality, health, environmental and safety standards for smooth market access.

Electrical safety and EMC

cetecom advanced has many years of experience in electrical safety and EMC testing and is recognized as a testing service provider for the testing of medical devices according to the Medical Device Directive 2017/745 (MDR) and 2017/746 (IVDR). cetecom advanced is accredited according to DIN/ISO/IEC 17025 by DAkkS and recognized by ZLG (Central Coordination Office for Human and Veterinary Medicinal Products in Germany).

We support you with a large portfolio:

Electrical safety testing:

  • EN/IEC 60601-1 / -8 / -11
  • EN/IEC 61010-2-66
  • including the required technical documentation such as risk management (ISO 14791),
    usability (EN/IEC 60601-1-6), software documentation (EN 62304), etc.
  • EN/IEC 61010-1
  • EN/IEC 61010-2-040 / -081 / -101
  • IEC 61010-031

EMC testing:

  • EN/IEC 60601-1-2
  • EN/IEC 60118-13
  • EN/IEC 61326-2-6

In addition, cetecom advanced is an accredited CB test laboratory for CB schemes
in the areas of electrical safety and EMC. We are also NRTL for North America.

Are you using wireless technology
in your medical device?

Medical devices that incorporate wireless RF technologies, such as BT, WIFI, DECT, radar, NFC, etc.,
must comply with the requirements of both the Medical and Radio Equipment Directives (2014/53/EU).

The European Union Radio Equipment Directive (RED) applies to all electrical and electronic equipment
that intentionally transmits and/or receives radio waves.

Other services in the field of medicine

Electroacoustic measurements of hearing aids for the Nordic, North American and European markets

  • Coexistence tests for the FDA
  • Environmental testing (e.g. vibration, shock, climate, IP classification)
  • Battery testing
  • Telecommunications certification body for USA (TCB), Canada (FCB)
  • Radio equipment certification body for Japan (RCB)
  • International type approval services around the world

Further topics