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Case Study

501(k) Gap Assessment in Response to Warning Letter

A large medical device manufacturer received an FDA 483 Observation and subsequent Warning Letter for failure to establish and maintain a design history file to demonstrate the design was developed in accordance with the approved design plan per 21 CFR820.30(j). This case study summarizes ECI's approach and comprehensive actions to execute the commitments made per the client's response to the FDA.

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Regulatory Affairs
Regulatory Compliance
Medical Devices
9/3/2024 19:44
Case Study
Case Study

Warning Letter: Corrective and Preventative Action

This case study describes ECI's approach to bringing its client's CAPA process into compliance after receiving several 483 inspectional observations and a subsequent Warning Letter by the US Food and Drug Administration (FDA).

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Quality
Regulatory Compliance
Medical Devices
9/3/2024 19:44
Case Study
Case Study

Warning Letter: Quality Management System Remediation

ECI was engaged by a medical device manufacturer to conduct a review of the company's Quality Management System to ensure a comprehensive response to several 483 Observations and Subsequent Warning Letter issues by the US Food and Drug Administration. ECI delivered a comprehensive assessment identifying areas of non-compliance, opportunities for improvement and remediation plan.

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Project Management
Quality
Risk Management
Regulatory Compliance
Medical Devices
9/3/2024 19:44
Case Study
Case Study

Design History File Integration via Acquisition

Post company acquisition, ECI was commissioned to conduct an assessment and subsequent remediation of the acquired product Design History Files (DHF). This case study describes the comprehensive actions required to remediate and integrate the products into the company's Quality Management System.

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Research & Development
Mergers & Acquisitions Support
Medical Devices
9/3/2024 19:44
Case Study
Case Study

EU MDR Regulatory Submissions

Our client, a Fortune 500 medical device manufacturer, identified hundreds of product families in need of preparation for the transition from the European Medical Device Directive (MDD) to the EU MDR regulation. The ECI team implemented a strong process to support the submission process and track Notified Body review status and responses for this multi-year project.

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Regulatory Affairs
Medical Devices
9/3/2024 19:44
Case Study
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