Pleasanton, CA – Spirometrix announced today that it has received ISO 13485 certification. ISO 13485 represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. It focuses on risk management effectiveness of corrective and preventive actions. It demonstrates a commitment from management for quality throughout the product development lifecycle and the product’s lifespan with customers.
Spirometrix is excited to have achieved this certification as it sets the groundwork to achieve the United States Food and Drug Administration (FDA) Class II medical device designation and meeting the Medical Devices Directive 93/42/EEC requirements in the European Union.
“At Spirometrix, we are committed to developing the highest quality products in compliance with international standards and regulatory authorities. Receiving ISO 13485 certification is recognition for the quality processes we have adopted and is a direct reflection of the commitment we have to deliver innovative products in respiratory health.,” says Brian Awabdy, Director of Engineering Reliability and Quality at Spirometrix, Inc.
Spirometrix is based in Pleasanton, California focusing on research, development and commercialization of novel breath analysis devices for application in disease diagnosis and management. Our mission is to provide cost effective, non-invasive products for the management of chronic pulmonary diseases such as Asthma, COPD, Cystic Fibrosis and Pulmonary Hypertension. Through the use of new sensors, proprietary algorithms and consumer technology we aim to improve health outcomes through preventive healthcare. http://www.spirometrix.com
For further information, please contact:
Director of Engineering Reliability and Quality