Clinical Evaluation for Neurovascular Guide Catheters
PMS Documentation for Cold Compression-Based Pain Management Devices
Project Summary
A medical device company specializing in wearable cold therapy solutions for post-operative pain management sought full-spectrum regulatory support for a novel Class IIb cold compression device and a legacy cold therapy product. The project scope included initial CEP and CER development for combined products, PMCF planning with sample size calculation, PMCF report generation, PSUR preparation, annual maintenance updates, and NB comment and CAPA resolution.
Celegence Solution & Approach:
Celegence supported the company for the following activities:
Highlights:
Authored the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) in compliance with EU MDR 2017/745
Conducted gap analysis of existing PMCF and clinical data; addressed all clinical evaluator and notified body comments
Identified suitable equivalent devices from a landscape scan of over 50 marketed products due to limited subject device data
Developed a robust State-of-the-Art (SOTA) review and established precise, validated thresholds for safety and performance
Statistically demonstrated non-inferiority to similar devices using adhesive comparators; mapped endpoints to intended use and product claims
Supported CAPA closure by aligning NB feedback with internal SOPs and improving internal documentation practices
Designed PMCF Plan with sample size calculations and authored PMCF Report
Developed and updated PSUR and SSCP (including patient SSCP), ensuring compliance with NB readability requirements
Delivered high-quality annual updates for all documents under tight timelines
Represented the company as SME consultants during NB meetings to justify strategy and evidence
Project Achievements
Celegence continues to deliver end-to-end regulatory support with a focus on stakeholder collaboration to achieve:
High-quality documentation delivered within tight deadlines across multiple concurrent projects
Successful CE marking for both novel and legacy cold therapy devices
Acceptance of proposed equivalence strategy, statistical justifications, and PMCF activities by the NB
Closure of NCs and approval of updated documentation post audit and NB feedback
Project Success
Strategic use of regulatory expertise, deep product understanding, and alignment of documentation with NB expectations enabled smooth approvals with minimal iterations—even in the absence of robust subject device data.
Need MDR-Compliant Support for Cold Therapy or Similar Devices?
From PMCF planning and statistical justifications to successful CE marking and NB interactions—Celegence delivers full-spectrum regulatory support tailored to your device needs.
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02 Feb, 2026
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