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MPO Medtech Forum 2025

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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
3/17/2025 18:53
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
3/17/2025 18:53
Case Study
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
3/17/2025 18:53
Case Study
Case Study

Regulatory Strategy

ECI was engaged by a medical device manufacturer to define a regulatory strategy for a new product development project involving multiple medical devices including an artificial intelligence feature.

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Regulatory Affairs
Medical Devices
3/17/2025 18:53
Case Study
Case Study

Risk Management File Conversion for EU MDR & EN ISO 14971

This case study provides an example of a risk management file remediation project starting with an impact assessment and subsequent steps to demonstrate conformance to the state of the art with a process to support alignment of the company quality management system documentation.

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Quality
Risk Management
Regulatory Compliance
Medical Devices
3/17/2025 18:53
Case Study
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