Electromagnetic Compatibility Directive (89/336/EEC).

Medical devices with an electric energy source must comply with the Electromagnetic Compatibility Directive (EMC). KEMA is a Competent Body under this Directive and can provide the necessary testing and certification. We have been officially designated to implement the complete conformity assessment of the EMC Directive for access to the EU market. KEMA is also accredited to grant access to markets in other countries. Moreover, you can call on KEMA for certification of your Quality System. 
  • KEMA has a global presence 
  • Specialists with extensive experience in the medical industry assess your products 
  • KEMA keeps the time to market as short as possible thanks to a special program
  • All your testing and certificates at one institute: In addition to EMC testing, you can also call on KEMA for IEC 601 tests, 510(k) reviews, and ISO 13485.

More information? Contact us.

< back to Medical services

Rate This Page: