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Grifols Receives ISO 13485:2003+AC:2009 Quality Management Certification for its Medical Devices

Wed, 01/18/2012 - 4:50am
LOS ANGELES/PRNewswire/ -- Grifols, a global healthcare company and biopharmaceutical manufacturer based in Barcelona, Spain, announced that its U.S. diagnostic and hospital divisions have received ISO 13485:2003+AC:2009 certification, an international quality standard that sets forth voluntary benchmarks for the design, manufacture and distribution of medical devices.

Grifols is the third largest global producer of medicines derived from human plasma and a manufacturer of diagnostic tools, hospital products and medical devices. ISO 3485:2003+AC:2009 certification demonstrates a company's adherence to a quality management system that administers and oversees a wide range of safety, compliance and regulatory standards related to medical devices. 

Grifols' medical devices are produced in Barcelona, Spain and are distributed in the U.S. through its Miami location. 

About Grifols

Grifols is a global pharmaceutical company develops and produces plasma-derived therapies and manufactures hospital pharmacy products, intravenous solutions, diagnostic tools and medical devices. As the third largest global producer of plasma therapies, Grifols has a presence in more than 90 countries and is the world leader in plasma collection, with 147 plasma donation centers across the U.S. The company's class A shares have been listed on the Spanish Stock Exchange since 2006 and have been part of the Ibex-35 since 2008. In 2011, the company listed non-voting class B shares on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ via ADRs.  

About ISO

The International Organization for Standardization (ISO) is the world's largest developer and publisher of international standards that apply to business, government and society. ISO is a network of the national standards institutes of 163 countries, with a central secretariat in Geneva, Switzerland that coordinates the system. ISO is a non-governmental organization that forms a bridge between the public and private sectors and enables consensus to be reached on solutions that meet the requirements of businesses and the broader needs of society.

Posted by Sean Fenske, Editor-in-Chief, MDT

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