Your active medical devices must comply with the IEC 601Directive (IEC 60601) as a component of the 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 601(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
• In addition to the IEC 601(IEC 60601), you can also call on KEMA for such things as 510(k) and ISO 13485:2003. That makes a big difference in terms of time and money. One-stop shopping. All your testing and certificates at one institute: KEMA
• 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.       

For more information please contact us.