Case Study: MDR Consulting & CER Writing for Cardiac Imaging and Image Processing Software
Background – Client Needs:
These Class IIa software capture, display, enhance, and save digital images from various digital imaging systems. Celegence created the CEP, CER, and LSR, and supported the customer in drafting responses to NB observations and remediation of the CER to meet NB expectations.
The manufacturer of a Class IIa standalone, imaging application intended for post-processing and evaluation of cardiac magnetic resonance (MR) and computed tomography (CT) images in DICOM format required MDR support. The product is used as a secondary diagnostic device by cardiologists, radiologists and other clinical/product specialists for visualization, measurement, and diagnostic purposes.
Celegence Solution & Approach:
Celegence created CEP and CER on MDR compliant templates, in conformance with MDCG and IMDRF guidance documents on Medical Device Software (MDSW) and Software as Medical Device (SaMD). Celegence provided the customer a detailed Gap Assessment and consultation support for closing gaps in their previous Clinical Evaluation for compliance with MDD and expanded the scope of EU MDR Gap Analysis to provide advisory consultation for MDR compliance.
Project Achievements
Based on their positive experience, the customer extended the scope of work to seek support for MDR compliant documentation for this device as well as the second device, a Class IIa medical device software for visualization, pre-operative planning and sizing in the Left Atrial Appendage Closure (LAAC) procedure using CT data.
Project Outcomes
The clinical evaluation documents for both devices were reviewed and accepted by the Notified Body with no observations and the devices obtained CE Marking.
