Medical

Product Description

KEMA Quality is Notified Body for the following directives : Active Implantable Medical Devices (90/385/EEC), Medical Devices (93/42/EEC), and In Vitro Diagnostic Medical Devices (98/97EEC).

Compliance with the Directives is shown by CE marking.

KEMA also conducts tests according to the safety stanrard for electric-medical devices (IEC 60601-series).

Futhermore, KEMA Quality is accredited by the FDA (Food and Drug Administration) to perform Third-Party Review of 510(k) submissions of certain eligible devices.