Zoll Circulation is a manufacturer of an innovative medical device that performs automatic chest compression in a compromised heart beat situation. Zoll partnered with KEMA to achieve certification to the Medical Device Directive and ISO 13485:2003. 

When someone’s heart stops beating, emergency care personnel on the ambulance or in the hospital, have to react very quickly and adequately. Normally they have to make use of manual CPR chest compressions. Manual compressions may result in fractured ribs or other trauma. 
The US manufacturer Zoll Circulation has developed a device that automat­ically calibrates itself to the patient’s size and performs proper automatic chest compressions. The AutoPulse Noninvasive Cardiac Support Pump is the first fully automated chest com­pression system designed to facilitate the ability to perform repeatable, high quality chest com­pressions on patients suffering a cardiac arrest.

Safe
Zoll Circulation turned to KEMA for the initial phases of receiving their CE certification to the Medical Device Directive. KEMA also performs their quality system registration to ISO 13485:2003. Since this was a new technology and a groundbreaking device, KEMA took care to ensure the device was safe and performed well. Initially KEMA only certi­fied the device for one year and required addi­tional post market feedback. Since then, Zoll has been able to show that in use the device is safe and performs very well. KEMA provided insight during audits and considered various solutions to the implementation of Zoll’s quality processes that not only comply with the stan­dards but are optimal for its particular business.