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ECI Recognized as a 2025 Boston Scientific Indirect Sourcing Supplier Award Winner

As part of Boston Scientific’s 2025 Supplier Awards, ECI was honored with the Inclusive Indirect Sourcing Supplier Award, recognizing our team's outstanding performance, responsiveness, and cross-functional collaboration. This acknowledgment highlights the trust and partnership built between ECI and one of the world’s leading medical device innovators.

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Case Study

Internal Audits

A small medical device manufacturing company was challenged with maintaining daily Quality System activities, including conducting internal audits. ECI provided support to successfully schedule and execute the company's internal audit program per their procedures.

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Quality
Medical Devices
3/17/2025 18:53
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
3/17/2025 18:53
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
3/17/2025 18:53
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
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
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