NEW YORK (GenomeWeb News) – Atlas Biolabs today said that it has achieved DIN EN ISO 13485:2003 + AC:2009 standard, allowing the company to develop a software-based expert system for assessing chromosomal aberrations.
The system will complement Atlas' genotyping and molecular karyotyping services.
According to the company, the certification is a milestone for Atlas and compliance is necessary 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 said in a statement.
The company had been certified according to DIN EN ISO 9001 since 2008.
Based in Berlin, Atlas provides genomics services, such as microarray-based genomic services, targeted sequence capture, and next-generation sequencing analysis.