NEW YORK (GenomeWeb News) – Molecular biology enzymes manufacturer Enzymatics today said that it has received ISO 13485:2003 and 9001:2000 standards certification from TÜV SÜD America.
The Beverly, Mass.-based firm makes proteins that are used for research and diagnostics purposes with a focus on nucleic acid detection technologies. It provides enzymes and buffer solutions for the Polonator, a low-cost sequencing system developed by George Church's group at Harvard Medical School and sold by the Dover unit of Danaher-Motion.
ISO 13485:2003 is a globally recognized standard that specifies requirements for a quality management system and is intended to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 9001:2000 shares significant overlap with 13485:2003, while including a focus on continuous improvement and customer satisfaction, said Enzymatics.