ORA™ has obtained the ISO13485 certification for Medical Devices

Philippeville, Belgium, June 7th 2014 / Optimized Radiochemical Applications (ORA™) today announced that it has obtained the ISO 13485 certification for Medical Devices.

In October 2010, ORA was selling its first NEPTIS synthesizer in the US. Since then, the company has manufactured and installed over 100 NEPTIS synthesizers worldwide. In 2013, ORA has expanded its range of products with three new models. The company is now already present with installations on five continents.

As to continue its growth worldwide as well as to meet the most strictest regulatory requirements, in particular for some countries like Japan, and ultimately increase the overall confidence of its customers in the quality of the products that ORA delivers to them, the management has made the decision early 2013 to seek for the most complete ISO 13485 certification for Medical Devices. The company had to recruit extra personnel in order to meet the ISO certification requirements and in particular an experienced Quality Assurance manager from the pharmaceutical industry. The already existing Quality Assurance system has been further tuned to meet the ISO requirements.

As a result, on April 28th 2014, the Management System of ORA has been assessed and certified as meeting the requirements of ISO 13485:2003 and EN ISO 13485:2012 for the design, development, manufacture and distribution of NEPTIS system (synthesizer for the automated production of [18F] fluoride based radiotracers).
PET Synthesizer ISO logo SGS UKAS 01

Vincent Tadino, Chief Technical Officer of ORA commented on this news: “The ISO certification is concretizing the efforts and the substantial investment made by ORA to reach this internationally recognized quality standard. It represents therefore also a major milestone for the continued expansion of our activities and gives to our customers the guarantee that our products are meeting the highest quality standard.”

OR is exhibiting at booth number #208 at the Society for Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting 2014 from 7-11 June in St Louis, US.

About NEPTIS

NEPTIS synthesizers, dedicated for the production of PET radiopharmaceuticals, aimed since their inception to address the various challenges, different by nature, of personalized medicine, a young but rapidly advancing field of healthcare: restoring freedom for researchers with an open and flexible platform, providing developers with a robust tool from clinical trials to commercial production, and offering producers a guarantee of reliable and repetitive performance. Additional information about NEPTIS is available at www.neptis-vsa.com.

About Optimized Radiochemical Applications (ORA™)

ORA, an innovation-driven Belgian company founded in 2006, is developing an extensive range of PET synthesizers for existing and new radiopharmaceuticals, and collaborates with major research institutions and pharmaceutical companies worldwide.  Additional information about ORA is available at www.oradiochem.eu.

For immediate release

Contact: Vincent Tadino
Phone: (0032) 71 61 40 53
Email: info@oradiochem.eu

©ORA Belgium, 2014. All rights reserved. PR14010
NEPTIS® is a trademark of ORA™

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