THE HEARX GROUP OFFICIALLY RECEIVES CE MARKING

August 5, 2019

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The hearX Group is pleased to announce that we’ve officially received our CE (Conformité Européenne) certification for hearTest™. This most recent certification joins the mantle next to our other certifications and registrations including FDA (Food and Drug Administration), ISO 13485 (International Standards Organisation), and SAHPRA (South African Health Products Regulatory Authority), for this product. The CE mark is a legal requirement to place a device on the market in the European Union (EU).

CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives. The Directives outline the safety and performance requirements for medical devices in the EU. Compliance with EU Directives requires you to meet specific standards of performance, quality, safety, and efficacy for your product type.

hearTest™ is a smartphone pure tone audiometry solution, offering advanced features with cloud-based data management. The process for hearTest™ to become CE certified started mid 2016 and involved implementing, certifying and maintaining a quality management system (ISO 13485) and performing extensive product testing. In addition, clinical evaluation, the submission of reports and technical files, and undergoing various audits by a notified body formed part of the process.

The CE mark provides the benefit of free movement of a product throughout the 30 member countries of the European Free Trade Area (EFTA) and provides an extra layer of assurance to our customers that hearTest™ conforms to the strictest safety and performance requirements. The hearX Group looks forward to the opportunities that await in Europe for hearTest™, as we continue on our mission to provide healthy hearing for everyone, everywhere.

For more information on hearTest™ or on the rest of our product suite, please contact us at info@hearxgroup.com.

For more information on hearX Group, please visit: hearxgroup.com

Disclaimer: The opinions expressed in the publications are those of the authors. They do not reflect the opinions or beliefs of hearX Group or its subsidiaries. The information contained herein is solely for informational purposes. It is not intended to be a substitute for professional medical advice and should not be relied upon as healthcare or medical advice. You are advised to seek guidance from your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking medical advice or care because of the content published herein. If you choose to rely on any information provided by hearX Group or its subsidiaries, you do so entirely at your own risk.

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