Case Study

PMS Documentation for Cold Compression-Based Pain Management Devices

Project Summary

A medical device and digital health company focused on innovative wearable technologies for high-risk cardiovascular patients required comprehensive regulatory support for a novel Class III implantable cardiac defibrillator. The scope involved initial Clinical Evaluation Plan (CEP) and Report (CER) development for CE marking, NB comment addressal, PMCF planning including sample size calculation, PAS protocol development for U.S. FDA submission, annual maintenance, and audit support.

Celegence Solution & Approach:

Celegence supported the company for the following activities:

Highlights:

Authored the CEP and CER in compliance with EU MDR 2017/745

Assessed adequacy of clinical data for a novel product with no prior market history

Conducted rapid risk mapping and analysis of over 500,000 adverse events from global databases for similar devices

Developed State-of-the-Art (SOTA) literature review and benchmarked precise, validated, and clinically justifiable threshold values for safety and performance

Identified and referenced marketed comparators with similar adhesives to support threshold justification

Designed PMCF strategy and calculated sample sizes; leveraged IDE data to reduce PMCF costs

Developed and gained approval for a PAS protocol for U.S. FDA, with appropriate sample size rationale

Supported NB comment addressal (resolved within 2 rounds) and provided real-time audit assistance

Authored and updated SSCPs, including patient versions written in plain language, validated using Flesch-Kincaid readability metrics

Delivered annual updates for regulatory documents within tight timelines and without deficiencies

Project Achievements

Celegence continues to deliver regulatory documentation via an end-to-end process involving the right stakeholders to achieve:

98% quality & timeline delivery performance despite tight timelines, an achievement in collaborating with Celegence’s expertise

Regulatory approval of PAS in the U.S. and acceptance of PMCF leveraging pre-existing study data

Efficient NB engagement with limited review cycles and no rejections

Successful CE marking

Project Success

Effective cross-functional collaboration, data-driven regulatory strategies, and expertise in integrating global clinical requirements enabled rapid approvals and minimized regulatory burden for a first-of-its-kind device..

Need Regulatory Support for Class III or Novel Devices?

Celegence delivers end-to-end MDR and FDA compliance support—including CEPs, CERs, PMCF, PAS protocols, and audit readiness—ensuring quality, speed, and successful approvals. Email us at info@celegence.com

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From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.

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PMS Documentation for Cold Compression-Based Pain Management Devices​​