Case Study: Clinical Evaluation of Cardiovascular Imaging Software
Background – Client Needs:
Manufacturers of standalone, cardiac imaging software intended for visualization and post-processing of diagnostic computed tomography and magnetic resonance images required support for addressing Notified Body observations for a previously submitted CER, subsequent remediation of the same, followed by creation of MDR complaint CEP & CER for a new software product in support of initial CE Marking.
Project Initiation & Key Objectives:
The client chose to leverage Celegence’s team of CER experts to support the CEP and CER Writing and remediation projects based on our extensive expert network and ability to complete the project in a cost-efficient and timely manner.
The scope of Celegence’s deliverables included:
Celegence Solution & Approach:
Celegence supported the company for the following activities for their Class IIa medical device software:
Celegence delivered high-quality regulatory documentation via an end-to-end process involving the right stakeholders to achieve:
Key to the success of this partnership was the involvement of an expert regulatory team that understood the needs of the manufacturer, and implementation of best practices, based on prior experience of addressing NB comments. Clinical Evaluation related deliverables created by Celegence were commended by the Notified Body and went through the approval process without any further observations, resulting in a satisfied client and recurring partnership with Celegence.