Limbus achieves EN ISO 13485:2016 certification
Limbus’ quality management system has now been certified to be compliant with the medical device standard EN ISO 13485:2016. This paves the way for future product conformity assessments as required by the new EU IVD regulation.
Since its inception Limbus has operated as a medical device manufacturer applying an ISO 13485-compliant quality management system. Limbus’ varvis® software has been declared a CE class I medical device from its launch in 2016. Limbus has now officially achieved EN ISO 13485 certification of its quality management system.
“With the new MDR and IVDR just around the corner, the official EN ISO 13485 certification lays the groundwork for all conformity assessments of future Limbus products according to the IVDR,” explains Dr. Sonja Strunz, Manager Quality and Regulatory Affairs.
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.
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. It is a harmonized European standard. Manufacturers or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.
Dr. Ben Liesfeld, Managing Director, adds: “Quality management is a team effort at Limbus. Every member of our team is committed to deliver products and services which fulfill highest standards.”
“The new European regulations will impose very strict rules on healthcare and laboratory service providers. 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.
About varvis
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. varvis is a complete solution for the entire NGS workflow, supporting automated NGS raw data processing, genomics data management, and variant interpretation, significantly increasing the efficiency and diagnostic yield in clinical genetics. varvis is a Class I medical device compliant with EU regulations. For more information about varvis, visit http://www.varvis.com.
