Company Performance Metrics
Sertio provides conformity assessment and certification services for in vitro diagnostic medical devices under the EU In Vitro Diagnostic Regulation. The company acts as an EU notified body for IVDR, assessing device conformity and quality management systems of IVD manufacturers and subcontractors. Sertio evaluates devices across applicable risk
classes and issues EU certificates where notified body involvement is required. It conducts assessments of manufacturers’ quality management systems in line with IVDR requirements and ISO 13485 accreditation. Sertio focuses on supporting manufacturers through the IVDR transitional timelines by reviewing applications and contracts necessary for market access. Its services are aimed at legal manufacturers seeking CE marking and regulatory compliance for IVD devices in the EU and EEA markets.
