ATLAS Biolabs fulfills requirements of DIN EN ISO 13485:2003 + AC:2009 standard for development and manufacturing medical devices
(firmenpresse) - Berlin, May 11, 2011 - By gaining certification according to the internationally recognized quality standard DIN EN ISO 13485:2003 + AC:2009, ATLAS Biolabs GmbH has reached another milestone in its advances in the field of molecular diagnostics. DIN EN ISO 13485:2003 + AC:2009 provides the criteria for quality management in the design and manufacture of medical devices; and compliance with this standard is required in order to develop and distribute software that falls within the scope of the European directive 98/79/EC for in vitro diagnostics. The new certificate gives the company a stronger position in molecular diagnostics and makes it an ideal partner for other companies that are looking to develop or have developed in vitro diagnostic tools. ATLAS Biolabs has been certified according to DIN EN ISO 9001 since 2008.
The newly acquired certification allows the company to develop a software-based expert system for evaluating chromosomal aberrations which will complement its existing genotyping and molecular karyotyping services. "The development of such an expert system is based on the experience we have gathered over many years in processing and analyzing hundreds of samples submitted by cytogenetic laboratories and academic institutions specialized in human genetic testing. From our discussions with physicians, we have understood that gathering, linking and interpreting all the information available is a laborious task and that such an expert system needs to be developed very carefully," said Peter Nürnberg, CEO of ATLAS Biolabs. ATLAS Biolabs" new expert system will support physicians needing to evaluate the different kinds of information linked to aberrations that could be responsible for the observed phenotypes. It will also be subject to risk management according to ISO 14971:2007.
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About ATLAS Biolabs GmbH
ATLAS Biolabs GmbH is a leading provider of complex analyses in molecular genetics, including microarray-based genomic services, targeted sequence capture and next-generation sequencing, in Europe. The company has access to the DNA chip platforms of all leading enterprises in this field (Affymetrix, Agilent, Illumina and Roche NimbleGen) and is a Certified Affymetrix, Agilent and Roche NimbleGen Service Provider. Based in Germany, ATLAS Biolabs started its business operations in August 2007. Its production processes are subjected to rigorous quality control in accordance with the international standards ISO 9001:2008 und ISO 13485:2003 + AC:2009. Customers of ATLAS Biolabs include academic institutions, pharmaceutical and biotechnological enterprises, clinicians and registered physicians both in Germany and abroad. For more information, please go to www.atlas-biolabs.com.
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Datum: 11.05.2011 - 09:40 Uhr
Sprache: Deutsch
News-ID 1023420
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contact information:
Contact person: Dr. Karsten Heidtke
Town:
Berlin
Phone: +49 (0) 30/3 19 89 66-0
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Electronics & Semiconductors
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