ac.biomed GmbH

medical devices

About

ac.biomed is one of the world's leading testing laboratories for cardiovascular medical devices. With our broad range of testing methods and services, we support our clients from the first test sample up to device approval and beyond, including regular production. If there is no standard available for your device, ac.biomed offers to develop new test methods and components for reliable experimentation. Our standard laboratory testing and service documentation are certified to ISO 9001 and compliant to ISO 17025. We have been approved through witness audits by internationally recognized regulatory bodies. Our heart valve testing is designed to meet all of ISO 5840 and current FDA heart valve requirements. We offer testing methods for oxygenators, blood pumps and other devices in compliance with international standards and guidelines.

Technologies

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Keywords

accelerated wear testing hydrodynamic testing circulatory simulation hemolysis & thrombogenicity oxygenator tests flow field analysis iso 5840 astm f1841 mechanical heart valve prostheses biological heart valve prostheses rotary & pulsatile blood pumps medical equipment manufacturing cardiovascular device testing iso 17025 heart valve testing device performance evaluation custom test development blood flow simulation blood pump testing clinical approval support oxygenator testing regulatory compliance regulatory approval iso 9001 thrombogenicity assessment medical devices medical device validation silicon vessel models healthcare testing services

Location

Aachen, North Rhine-Westphalia, Germany

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