JD Technologies Global, LLC is proud to announce that their principal, Roush Yates Manufacturing Solutions (RYMS) has received the ISO 13485 certification
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Dante Labs, a world leader in genomic sequencing and data analysis, announced today that it received ISO 13485:2016 certification for its Immensa Genomic Interpretation Software as a medical device. The highly coveted industry certification involved a deep clinical validation study carried out by several teams at Dante Labs over an 18 month period. The accreditation was awarded by The British Standards Institution (BSI) Group.
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Dante Labs Automatic Lab (Photo: Business Wire) This is a great achievement for all of the team members at Dante Labs who worked very hard to implement a brand-new ISO-compliant quality system and develop the software, says Dante Labs CEO Andrea Riposati. The bioinformatics team ran a clinical validation study the size of a population genomics program.
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