![]() The clinical decision support system varvis, designed by Limbus Medical Technologies GmbH, Rostock, Germany, is a cloud-based software system to filter and evaluate genetic sequencing data. ![]() ![]() We do our part such that physicians and geneticists can trust the software tools they are using and focus on the center of all our efforts: the patient,” he concludes. “The new European regulations will impose very strict rules on healthcare and laboratory service providers. Every member of our team is committed to deliver products and services which fulfill highest standards.” Ben Liesfeld, Managing Director, adds: “Quality management is a team effort at Limbus. ![]() Manufacturers or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.ĭr. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. IVD devices related to genetic testing will most likely be classified as Class C and thus subject to an external conformity assessment of a notified body according to IVDR.
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