Insights

Benefits of Product Design Due Diligence for Successful Integration

Join Shital Patel, COO of ECI, as she shares insights on ensuring value creation through effective product design assessments during acquisitions. Perfect for professionals involved in M&A, product development, and quality assurance in the medical device industry. Thursday, September 26, 12pm EDT

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

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

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

9/3/2024 19:44

Case Study

Pulse Oximeter Manufacturing Transfer

A Fortune 500 medical device manufacturer was face with an increased demand for its Pulse Oximeter devices during the beginning of the COVID pandemic. This case study describes ECI implementation of a master validation plan to fully implement five production lines in a Costa Rica manufacturing facility.

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Manufacturing Engineering

Medical Devices

9/3/2024 19:44

Case Study

Warning Letter: Regulatory Responsibility

Our client, a large medical device company, received several 483 inspectional observations and a subsequent Warning Letter from the United States Food and Drug Administration (FDA). This case study describes ECI's approach to an assessment plan and remediation activities in order to provide a robust proposal for each cited violation.

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Regulatory Compliance

Compliance

Medical Devices

9/3/2024 19:44

Case Study

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Benefits of Product Design Due Diligence for Successful Integration

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