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:

  • Software Device 1: Gap Assessment, Addressing NB observations, CER Remediation
  • Software Device 2: CEP and CER for initial CE-marking

Celegence Solution & Approach:

Celegence supported the company for the following activities for their Class IIa medical device software:

  • Creation of CEP and CER templates compliant with EU MDR requirements
  • Software Device 1 (CER Remediation):

    • Analysis of Notified Body observations and detailed Gap assessment of the previous CER submission
    • Consultation support and remediation of the Clinical Evaluation Report by addressing identified Gaps and NB observations
  • Software Device 2 (Initial CE-marking):

    • Assessment of the current manufacturer data and clinical evidence available for the software
    • Scope extension to include a Clinical Validation Plan and Report to further strengthen the clinical evidence on the device
    • Creation of CEP and CER in accordance with MDCG and IMDRF guidance documents
  • Advisory consultation for MDR compliance related to Usability testing, PMS Plan, and PMCF activities.

Project Achievements

Celegence delivered high-quality regulatory documentation via an end-to-end process involving the right stakeholders to achieve:

  • High quality delivery within expedited timelines.
  • Improved compliance based on guidance from Celegence’s regulatory experts.

Project Outcomes

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.

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