CIRCA Scientific's Quality Management System Awarded EU-MDR Certification
ENGLEWOOD, Colo., Sept. 7, 2022 /PRNewswire/ -- CIRCA Scientific announced that the company has successfully met the requirements for certification of its Quality Management System (QMS) under the new European Union Medical Device Regulation (MDR) as of August 24th, 2022. To earn this certificate, BSI Group, CIRCA Scientific's notified body, completed a comprehensive conformity assessment and confirmed compliance of its QMS with the new, strengthened safety and performance requirements of the MDR. MDR certification allows CIRCA Scientific not only to continue to distribute its existing products in European markets but opens the door to proceed with its plans for new product developments and launches in the EU.