CAPTIS™: MDD to MDR CER Remediation of a Standalone Software
CER Writing Support: Clinical Evaluation of Clinical Decision Support Software
Project Summary
A leading pharmaceutical company required support for authoring EU MDR compliant Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER) and Post-Market Clinical Follow-up (PMCF) Plan for initial CE-marking of a Class IIa medical device software (MDSW).
The software is intended for use by Healthcare Provider (HCPs) in clinical practice to assist in monitoring the risk of progression from relapsing-remitting multiple sclerosis (RRMS) to secondary progressive multiple sclerosis (SPMS), thereby facilitating physician–patient interaction and aiding in clinical decision-making related to disease progression.
Celegence Solution & Approach:
Celegence team provided medical writing and regulatory consultation services through the entire process of NB review. This included:
Highlights:
Comprehensive literature review for the medical device and the State-of-the-Art
Evaluation of non-clinical and clinical data generated and held by the manufacturer
Real-world evidence from adverse event databases
Robust analysis of the safety, performance, and benefit-risk profile of the devices to demonstrate conformity to General Safety and Performance Requirements outlined in the EU MDR.
Project Achievements
Celegence addressed two rounds of observations and provided detailed responses to queries from the NB. The customer appreciated the support provided by Celegence and the adaptability of the team.
Project Success
The Celegence’s end-to end document writing process and involving right stake holders lead to high quality clinical documentation achieving: >98% quality & timeline delivery performance despite tight timelines Improved regulatory complaint documents based on guidance of Celegence’s regulatory experts Key to success of this partnership was a highly adaptable team of writers who worked in tandem with the client’s team and experts who understood the gaps in the documents queries from the NB reviewers. .
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25 Mar, 2025
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