ATLAS Biolabs fulfills the DIN EN ISO 13485:2003 + AC: 2009 standard for designing and manufacturing medical devices
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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Topic world Diagnostics
Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.
Topic world Diagnostics
Diagnostics is at the heart of modern medicine and forms a crucial interface between research and patient care in the biotech and pharmaceutical industries. It not only enables early detection and monitoring of disease, but also plays a central role in individualized medicine by enabling targeted therapies based on an individual's genetic and molecular signature.