MDR (EU) 2017/745
Conformity assessment and certification under the European Medical Device Regulation for market access.
Learn MoreDiagnostic Equipment
CE marking and MDR certification for diagnostic imaging equipment, patient monitoring systems, and clinical diagnostic devices.
Certification for Diagnostic Equipment
Diagnostic equipment — from advanced imaging systems and patient monitors to point-of-care testing devices — plays a vital role in clinical decision-making. The accuracy, reliability, and safety of these devices directly impact patient outcomes, making rigorous certification essential.
Udem Atlantic provides MDR conformity assessment services for a broad range of diagnostic devices. Our technical reviewers have expertise in electrical safety standards (IEC 60601 series), software validation requirements (IEC 62304), and the specific clinical evaluation expectations for diagnostic technologies.
For manufacturers of software-driven diagnostic tools, we offer guidance on navigating the MDR's requirements for Software as a Medical Device (SaMD), including qualification, classification, and the specific technical documentation requirements for software-based devices. Our quality system certification process addresses the unique production and validation challenges of diagnostic equipment manufacturing.