IEC 60601.

Access to the European medical market

Your active medical devices must comply with the IEC 60601 as a component of CE certification. Only then will they be allowed on the European market. KEMA has several laboratories all over the world where these tests can be conducted. 

KEMA has been officially designated to completely implement the conformity assessment of the IEC 60601 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: One-stop shopping
  • KEMA has a global presence
  • All your testing and certificates at one institute: In addition to the IEC 60601, you can also call on KEMA for 510(k) and ISO 13485
  • 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.       

More information? Contact us.

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