“As a fast-growing organization and one looking to steadily unlock new global markets, it’s essential that we have watertight compliance across EU and other key jurisdictions,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “The new IVDR framework is a major revision, focusing on patient safety and increasing the emphasis on the life-cycle management and continuous evaluation of products in the European market. While it significantly increases the regulatory burden for IVD manufacturers like ourselves, with the deep expertise of our team and existing sophistication of our internal processes and ColoAlert product, we’ve been able to successfully meet all the required criteria for compliance effectively and efficiently and in good time to meet the May 26th, 2022 deadline.”
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